Clinical trial NCT04595565: Sacituzumab Govitecan in Primary HER2-negative Breast Cancer
Official title: Phase III Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-negative Breast Cancer Patients With High Relapse Risk After Standard Neoadjuvant Treatment - SASCIA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HER2-negative Breast Cancer
Triple Negative Breast Cancer
Lead sponsor: GBG Forschungs GmbH
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Austrian Breast & Colorectal Cancer Study Group
name: Spanish Breast Cancer Research Group (GEICAM)
name: ETOP IBCSG Partners Foundation
name: Cancer Trials Ireland
name: UNICANCER
First posted: 2020-10-20
Enrollment: 1332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:

* Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
* Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.

Treatment in either arm will be given for eight cycles.

In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.

Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

Detailed description: Neoadjuvant chemotherapy (NACT) allows monitoring of tumor response to treatment and a pathological complete response (pCR) is associated with superior survival. This association is strongest in the most aggressive subtype, i.e. in patients with triple-negative breast cancer (TNBC). Patients with TNBC not achieving a pCR have a 5-year event free survival rate of about 50%. The association between pCR and prognosis is less pronounced in HR-positive/HER2-negative patients. However, the CPS+EG scoring system for prognosis after neoadjuvant chemotherapy, taking into account clinical stage, post treatment pathological stage, estrogen receptor status and grade, leads to an improved estimate of prognosis allowing to select patients at high risk of relapse for post-neoadjuvant therapy. Patients with TNBC not achieving a pCR as well as those with HR-positive/HER2-negative tumors and a CPS+EG score of 3 or 2/ypN+ are at high risk of relapse, warranting additional experimental therapies after NACT.

There is proof of concept, that post-neoadjuvant therapy can significantly improve survival. First data was provided by the CREATE X trial, randomizing patients with residual tumor after neoadjuvant chemotherapy to either capecitabine or observation. CREATE X included HER2-negative patients and demonstrated a significant improvement in disease-free survival (DFS) and overall survival (OS) in the overall population, which was confined to the TNBC subgroup.

Recently, the randomized post-neoadjuvant phase III KATHERINE study demonstrated an improved invasive disease-free survival in HER2-positive patients without pCR after trastuzumab +/- pertuzumab treated postoperatively with T-DM1, an antibody-drug-conjugate compared to trastuzumab.

Sacituzumab govitecan has demonstrated unprecedented activity in heavily pretreated patients with metastatic triple-negative and HR-positive/HER2-negative breast cancer, even after prior immune-checkpoint inhibitors or CDK4/6 and mTOR inhibitors. Based on the results of the phase I/II study, sacituzumab govitecan was granted a breakthrough therapy designation for the treatment of patients with advanced or metastatic TNBC who have received at least two previous lines of treatment for metastatic disease. The efficacy of sacituzumab govitecan in advanced TNBC was confirmed in the phase III ASCENT trial. Based on this study, sacituzumab govitecan received regular approval. Additionally, the TROPiCS-02 study showed an improvement in progression-free survival and OS over single-agent chemotherapy and a manageable safety profile in patients with heavily pre-treated HR-positive/HER2-negative endocrine-resistant, unresectable locally advanced or metastatic BC.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
2. Age at diagnosis at least 18 years.
3. Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block from surgery after neoadjuvant chemotherapy and from core biopsy before start of neoadjuvant chemotherapy, which will be used for centralized prospective confirmation of HR status, HER2 status, Ki-67 and tumor-infiltrating lymphocytes (TILs) and for retrospective exploratory correlation between genes, proteins, and mRNAs relevant to sensitivity/resistance to the investigational agents. For patients with bilateral carcinoma, FFPE blocks from both sides have to be provided for central testing.
4. Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically by core biopsy. The lead tumor has to be defined by the investigator based on the inclusion criteria for the respective subtype and on the risk status.
5. Centrally confirmed HER2-negative (IHC score 0-1 or FISH negative according to ASCO/CAP guideline) and either

   * HR-positive (≥1% positive stained cells) disease or
   * HR-negative (\<1% positive stained cells) assessed preferably on tissue from postneoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion. If not evaluable, core of diagnostic biopsy will be used. In case of bilateral breast cancer, HER2-negative status has to be confirmed for both sides.
6. Patients with residual invasive disease after neoadjuvant chemotherapy at high risk of recurrence defined by either:

   * For HR-negative: any residual invasive disease \> ypT1mi and/or ypN1\>1mm
   * For HR-positive disease: a CPS+EG score ≥ 3 or CPS+EG score 2 and ypN+ using local ER and grade assessed on core biopsies taken before start of neoadjuvant treatment.
7. Adequate surgical treatment including resection of clinically evident disease and ipsilateral axillary lymph node dissection. SNB before NACT is discouraged. Axillary dissection before NACT is not permitted. Axillary dissection, including Targeted Axillary Dissection (TAD) should be performed according to guidelines. Histologic complete resection (R0) of all invasive and in situ tumors is required.
8. Patients must have received neoadjuvant taxane-based chemotherapy for 16 weeks (anthracyclines are permitted). This period must include 6 weeks of a taxane containing neoadjuvant chemotherapy (exception: for patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant chemotherapy, a total treatment period of less than 16 weeks is also eligible).
9. No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion if adequate local control could be obtained.
10. In case of local progression during neoadjuvant therapy, distant metastases must be excluded by adequate imaging (CT/MRI recommend) prior to entering the trial.
11. Immune checkpoint inhibitor / immunotherapy during (neo)adjuvant therapy is allowed until the completion of radiotherapy.
12. Patients with known gBRCA1/2 mutation without indication to adjuvant olaparib therapy are allowed to participate in the trial.
13. An interval of less than 16 weeks since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) and the date of randomization is required.
14. Radiotherapy should be delivered before the start of study treatment. Radiotherapy to the breast is indicated in all patients with breast conserving surgery and to the chest wall and lymph nodes according to local guidelines as well as in all patients with cT3/4 or ypN+ disease treated by mastectomy.
15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
16. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedure or radiotherapy to NCI CTCAE v 5.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patients at the investigator´s discretion).
17. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.
18. The patient must be accessible for scheduled visits, treatment and follow-up.
19. Normal cardiac function after neoadjuvant chemotherapy must be confirmed according to local guidelines. Results for LVEF must be above the normal limit of the institution.
20. Laboratory requirements:

    Hematology
    * Absolute neutrophil count (ANC) ≥1.5 x 109 / L
    * Platelets ≥100 x 109 / L
    * Hemoglobin ≥10 g/dL (≥6.2 mmol/L) Hepatic function
    * Total bilirubin \<1.25x UNL
    * AST and ALT ≤1.5x UNL
    * Alkaline phosphatase ≤2.5x UNL Renal Function
    * \<1.25x ULN creatinine or creatinine clearance ≥30 ml/min (according to Cockroft-Gault, if creatinine is above UNL).
21. Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. A woman is considered to be of childbearing potential if she is not postmenopausal. Postmenopausal is defined as:

    * Age ≥60 years
    * Age \<60 years and ≥12 continuous months of amenorrhea with no identified cause other than menopause
    * Surgical sterilization (bilateral oophorectomy and/or hysterectomy).
22. For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 6 months after the last dose of sacituzumab govitecan for female patients and for at least 3 months for male patients; for at least 6 months after the last dose of capecitabine or carboplatin/cisplatin for female patients and for at least 3 months after the last dose of capecitabine or 6 months after the last dose of carboplatin/cisplatin for male patients. Examples of non-hormonal contraceptive methods with a failure rate of \< 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices.
23. Complete staging work-up prior to the initiation of neoadjuvant chemotherapy. Missing staging investigations must be performed prior to randomization.

Exclusion Criteria:

1. Known hypersensitivity reaction to one of the compounds or substances used in this protocol.
2. Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible.
3. Patients with known gBRCA1/2 mutation and indicated or planned adjuvant olaparib therapy if available.
4. Patients with a history of any malignancy are ineligible with the following exceptions:

   * Patient has been disease-free for at least 5 years and is at low risk for recurrence of that malignancy
   * CIS of the cervix, basal cell and squamous cell carcinomas of the skin.
5. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to 6 months after sacituzumab govitecan and up to 6 months after treatment with capecitabine or carboplatin/cisplatin.
6. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study, including Gilbert´s disease, Crigler-Najjar-Syndrome, known hepatitis B, hepatitis C, known HIV positivity or known autoimmune disease other than diabetes, vitiligo, or stable thyroid disease, vitiligo, or other autoimmune skin disease with dermatologic manifestations only are permitted provided all of the following conditions are met:

   * Rash must cover \< 10% of body surface area
   * Disease is well controlled at baseline and requires only low-potency topical corticosteroids
   * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
7. Any condition that interferes with the safe administration of the treatment of physician´s choice in case the patient is randomized into the TPC arm.
8. Known or suspected congestive heart failure (\>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of prior infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP \>150/90 mmHg under treatment with at maximum three antihypertensive drugs), rhythm abnormalities requiring permanent treatment (excluding chronic atrial fibrillation not requiring a pacemaker), clinically significant valvular heart disease, supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;conduction abnormality requiring a pacemaker.
9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis on chest CT scan.
10. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving chemotherapy.
11. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
12. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
13. Known allergic reactions to irinotecan.
14. Concurrent treatment with:

    * Chronic corticosteroids prior to study entry with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or equivalent corticosteroid.

Primary outcomes:
measure: Invasive disease free survival (iDFS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
timeFrame: Assuming 3.25 years of recruitment with 12 months ramp-up and 42 patients per month at peak and 3 years of follow-up after the last patient in, 396 events will be needed and final analysis is expected 75 months after study start.
Secondary outcomes:
measure: To compare overall survival (OS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
timeFrame: Assuming 3.25 years of recruitment 398 events will be needed with a power of 80% and final analysis is expected after 99 months (8.3 years after first patient in, 2 years after final analysis of iDFS).
measure: Distant disease-free survival (DDFS) between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
timeFrame: DDFS will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)
measure: To compare the invasive breast cancer-free survival (iBCFS) between both groups.
timeFrame: iBCFS will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)
measure: Locoregional recurrences-free interval between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
timeFrame: Time-to-Event Outcome Measure up to 75 month after study start.
measure: iDFS in stratified subgroups.
timeFrame: Will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)
measure: OS in stratified subgroups.
timeFrame: Will be analyzed after 99 months (8.3 years after first patient in, 2 years after final analysis of iDFS)
measure: iDFS in exploratory subgroups.
timeFrame: Will be analyzed at the time of the final iDFS analysis (is expected 75 months after study start)
measure: OS in exploratory subgroups.
timeFrame: Will be analyzed after 99 months (8.3 years after first patient in, 2 years after final analysis of iDFS)
measure: Safety - To compare safety between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
timeFrame: Final safety analysis will take place when interim analysis of the primary endpoint is performed (all patients will have completed treatment, estimated 54 months from study start)
measure: Compliance - To compare dose-density, dose reductions, dose delays, treatment interruptions and treatment discontinuation rates between patients treated with sacituzumab govitecan vs. treatment of physician's choice.
timeFrame: Analysis with final safety analysis expected 54 months after study start.
measure: Patient reported outcome: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: Through study completion and until 12 months after End of treatment of single patients.
measure: Patient reported outcome: Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)
timeFrame: Through study completion and until 12 months after End of treatment of single patients.
measure: Patient reported outcome: Health Questionnaire 5-Level EQ-5D (EQ-5D-5L)
timeFrame: Through study completion and until 12 months after End of treatment of single patients.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MUG - Univ.-Klinik f. Frauenheilkunde u. Geburtshilfe Graz
city: Graz
country: Austria
facility: MUG - Univ.-Klinik f. Innere Medizin Graz
city: Innsbruck
country: Austria
facility: MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - BHS
city: Linz
country: Austria
facility: TumorZentrum Kepler Uniklinikum Linz
city: Salzburg
country: Austria
facility: LKH Salzburg - PMU
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vöcklabruck
country: Austria
facility: Salzkammergut-Klinikum Vöcklabruck
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wr. Neustadt
city: Wien
country: Austria
facility: MUW - AKH Wien
city: Wien
country: Austria
facility: MUW - Med. Univ.-Klinik AKH Wien
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Angers
country: France
facility: Institut de cancérologie de l'ouest (Angers)
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bourg En Bresse
country: France
facility: CH Fleyriat
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin 5
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
city: Nantes
country: France
facility: Hôpital privé du Confluent
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie (Paris)
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Plérin
country: France
facility: Hôpital Privé Des Côtes d'Armor- Centre CARIO-HPCA
city: Reims
country: France
facility: Institut Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Sarcelles
country: France
facility: Gcs Rissa
city: Strasbourg
country: France
facility: Institut de Cancérologie Strasbourg Europe-ICANS
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCTO
city: Tours
country: France
facility: CHU Bretonneau
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden- Württemberg
city: Böblingen
country: Germany
facility: Kreiskliniken Böblingen gGmbH
state: Baden-Württemberg
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: ViDia Christliche Kliniken Karlsruhe
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim, Frauenklinik
state: Baden-Württemberg
city: Nürtingen
country: Germany
facility: medius Kliniken gGmbH Nürtingen
state: Baden-Württemberg
city: Reutlingen
country: Germany
facility: Klinikum am Steinenberg
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dres. Heinrich / Bangerter
state: Bayern
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinik am Bruderwald
state: Bayern
city: Erlangen
country: Germany
facility: Universitätsklinik Erlangen
state: Bayern
city: Landshut
country: Germany
facility: Klinikum Landshur GmbH
state: Bayern
city: Traunstein
country: Germany
facility: Gemeinschaftspraxis Dr. U. Kronawitter/ Dr. C. Jung
state: Bayern
city: Berlin
country: Germany
facility: Charité Campus Mitte, BIH Charité Rahel Hirsch
state: Brandenburg
city: Fürstenwalde
country: Germany
facility: Schwerpunktpraxis der Gynäkologie und Onkologie
state: Brandenburg
city: Bad Nauheim
country: Germany
facility: Hochwaldkrankenhaus, Gesundheitszentrum Wetterau gGmbH
state: Hessen
city: Frankfurt
country: Germany
facility: Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus
state: Hessen
city: Frankfurt
country: Germany
facility: AGAPLESION Markus Krankenhaus
state: Hessen
city: Frankfurt
country: Germany
facility: Klinikum der J. W. Goethe Universität
state: Hessen
city: Hanau
country: Germany
facility: Klinikum Stadt Hanau
state: Hessen
city: Kassel
country: Germany
facility: Elisabeth Krankenhaus
state: Hessen
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH, Gynäkologische Ambulanz
state: Hessen
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
state: Hessen
city: Wiesbaden
country: Germany
facility: Helios Klinik Wiesbaden
state: Hessen
city: Rostock
country: Germany
facility: Klinikum Südstadt
state: Mecklenburg-Vorpommern
city: Braunschweig
country: Germany
facility: Studien GbR Braunschweig
state: Niedersachsen
city: Georgsmarienhütte
country: Germany
facility: MVZ II der Niels Stensen Kliniken
state: Niedersachsen
city: Hannover
country: Germany
facility: DIAKOVERE Henriettenstift Gynäkologie
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AöR
state: Niedersachsen
city: Stade
country: Germany
facility: MVZ in der Klinik Dr. Hancken
state: Niedersachsen
city: Wolfenbüttel
country: Germany
facility: Gemeinschaftspraxis Dallacker / Eilers
state: Niedersachsen
city: Bielefeld
country: Germany
facility: Onkologische Schwerpunktpraxis, Studiengesellschaft Onkologie Bielefeld GbR
state: Nordrhein-Wastfalen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: Nordrhein-Westfalen
city: Bottrop
country: Germany
facility: Marienhospital Bottrop gGmbH
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: St, Johannes Hospital
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität Düsseldorf
state: Nordrhein-Westfalen
city: Erkelenz
country: Germany
facility: Praxis Dr. B. Adhami
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung/Knappschaft GmbH
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: St. Elisabeth-Krankenhaus, Brustzentrum Köln-Hohenlind
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Kliniken der Stadt Köln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Praxisklinik für Hämatologie und Onkologie
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: Uniklinikum, Klinik für Geburtshilfe und Gynäkologie
state: Rheinland-Pfalz
city: Mayen
country: Germany
facility: Institut für Versorgungsforschung
state: Rheinland-Pfalz
city: Speyer
country: Germany
facility: Onkologische Schwerpunkt- Praxis Speyer
state: Rheinland-Pfalz
city: Worms
country: Germany
facility: Klinikum Worms
state: Rheinland-Pfalz
city: Saarbrücken
country: Germany
facility: Caritasklinik St. Theresia
state: Saarland
city: Halle
country: Germany
facility: Universitäsklinik Halle/Saale
state: Sachsen-Anhalt
city: Stendal
country: Germany
facility: Johanniter Krankenhaus Genthin-Stendal
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
state: Sachsen
city: Rodewisch
country: Germany
facility: Klinikum Obergöltzsch Rodewisch
state: Sachsen
city: Torgau
country: Germany
facility: Kreiskrankenhaus Torgau
state: Sachsen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen
state: Thüringen
city: Nordhausen
country: Germany
facility: MVZ Nordhausen gGmbH im Südharz Krankenhaus
state: Thüringen
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl
state: Thüringen
city: Augsburg
country: Germany
facility: Hämatologie-Onkologie im Zentrum MVZ GmbH
city: Berlin
country: Germany
facility: MediOnko-Institut GbR
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin Buch
city: Bottrop
country: Germany
facility: Marienhospital Bottrop gGmbH
city: Bremen
country: Germany
facility: Hämato-Onkologie im Medicum
city: Deggendorf
country: Germany
facility: DONAUISAR Klinikum Deggendorf
city: Hamburg
country: Germany
facility: Mammazentrum Hamburg
city: München
country: Germany
facility: Rotkreuzklinikum München
city: Passau
country: Germany
facility: Klinikum Passau
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH
city: Ravensburg
country: Germany
facility: MVZ für Hämatologie und Onkologie Ravensburg GmbH
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Bizkaia
city: A Coruña
country: Spain
facility: COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA-Hospital Teresa Herrera (CHUAC)
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Alcoy
country: Spain
facility: Hospital Virgen de Los Lirios
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Institut Catala D'oncologia
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Castellón De La Plana
country: Spain
facility: Consorcio Hospitalario Provincial de Castellón
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
city: Granada
country: Spain
facility: Hospital Universitario Clinico San Cecilio
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaén
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Mataró
country: Spain
facility: Consorci Sanitari Del Maresme
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de La Arrixaca
city: Málaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Llátzer
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
city: Sabadell
country: Spain
facility: Parc Tauli Hospital Universitari
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Ntra.Sra. de Candelaria
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (Chus)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de La Macarena
city: Sevilla
country: Spain
facility: Hospital Quirónsalud Sagrado Corazón
city: Sevilla
country: Spain
facility: University Hospital Virgen Del Rocio S.L.
city: Toledo
country: Spain
facility: Hospital Iniversitario De Toledo
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Consorci Hospital General Universitari de Valencia
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: València
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Vitoria
country: Spain
facility: Hospital Universitario Araba-Txagorritxu
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: St. Gallen
country: Switzerland
facility: Breast Center KSSG
city: Zürich
country: Switzerland
facility: Brust-Zentrum Zürich
Study officials:
affiliation: ASCO, ESMO, GBG, AGO, DKG, DGS, DKG
name: Frederik Marmé, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marmé F, Hanusch C, Furlanetto J, et al. Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment. ESMO Breast 2022; 58O, proffered paper presentation. https://doi.org/10.1016/j.annonc.2022.03.075