Clinical trial NCT06112379: A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
Official title: A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer;
Dato-DXd; DS1062a;
TROP2;
TNBC;
HR low:
Datopotamab deruxtecan;
Antibody Drug Conjugate;
ADC;
neoadjuvant therapy;
adjuvant therapy;
durvalumab;
PD-L1;
immune-checkpoint inhibitor (ICI);
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2023-11-01
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Primary purpose: TREATMENT

Brief summary: This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Detailed description: The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor low/HER2-negative breast cancer, by central assessment of pCR and/or to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by investigator assessment of EFS

Eligibility criteria: Inclusion Criteria:

* Participant must be ≥ 18 years, at the time of signing the ICF.
* Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
* ECOG PS of 0 or 1
* Provision of acceptable tumor sample
* Adequate bone marrow reserve and organ function
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and aligned with protocol requirements.

Exclusion criteria:

* History of any prior invasive breast malignancy
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization.
* active or prior documented autoimmune or inflammatory disorders.
* Evidence of distant disease.
* Clinically significant corneal disease.
* Has active or uncontrolled hepatitis B or C virus infection.
* Known HIV infection that is not well controlled.
* Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
* Known to have active tuberculosis infection
* Mean resting corrected QTcF interval \> 470 ms obtained from ECG
* Uncontrolled or significant cardiac disease.
* History of non-infectious ILD/pneumonitis
* Has severe pulmonary function compromise
* Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
* For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
* Concurrent use of systemic hormone replacement therapy or oral hormonal contraception

Primary outcomes:
measure: Pathologic Complete Response (pCR) in the experimental vs control arms
timeFrame: At the time of definitive surgery
measure: Event-free survival (EFS) in the experimental vs control arms
timeFrame: Date of randomization to date of the EFS event, up to 68 months after the first subject randomized
Secondary outcomes:
measure: Overall Survival (OS) in the experimental vs control arms
timeFrame: Date of randomization to date of death due to any cause, up to 82 months after the first subject randomized
measure: Distant disease-free survival (DDFS) in the experimental vs control arms
timeFrame: Date of randomization to date of the DDFS event, up to 68 months after the first subject randomized
measure: Participant-reported breast and arm symptoms in the experimental vs. control arms
timeFrame: From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first.
measure: Participant-reported physical function in the experimental vs. control arms
timeFrame: From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
measure: Participant-reported fatigue in the experimental vs. control arms
timeFrame: From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
measure: Participant-reported Global health status/Quality of life (GHS/QoL)in the experimental vs. control arms
timeFrame: From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
measure: Pharmacokinetics of Dato-DXd (in combination with durvalumab)
timeFrame: Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
measure: Pharmacokinetics of Dato-DXd (in combination with durvalumab)
timeFrame: Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
measure: Pharmacokinetics of Dato-DXd (in combination with durvalumab)
timeFrame: Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
measure: Immunogenicity of Dato-DXd (in combination with durvalumab)
timeFrame: Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
measure: Safety of Dato-DXd (in combination with durvalumab)
timeFrame: Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely
Other outcomes:
Locations:
city: Daphne
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state: Alabama
city: Goodyear
country: United States
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state: Arizona
city: Phoenix
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city: Los Angeles
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city: Barrie
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city: London
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city: Montreal
country: Canada
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state: Quebec
city: Montreal
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city: Montreal
country: Canada
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city: Sherbrooke
country: Canada
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country: Canada
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city: Saskatoon
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state: Saskatchewan
city: Montreal
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country: China
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country: China
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city: Changchun
country: China
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city: Changsha
country: China
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city: Changsha
country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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city: Hefei
country: China
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city: Jinan
country: China
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city: Kunming
country: China
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city: Linhai
country: China
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city: Nanchang
country: China
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city: Nanchang
country: China
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city: Nanjing
country: China
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city: Nanjing
country: China
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city: Nanning
country: China
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country: China
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country: China
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city: Shenyang
country: China
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city: Shijiazhuang
country: China
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city: Suining
country: China
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city: Suzhou
country: China
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country: China
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city: Urumqi
country: China
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city: Wuhan
country: China
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city: Xi'an
country: China
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city: Xintai
country: China
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city: Zhaoqing
country: China
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city: Zhengzhou
country: China
facility: Research Site
city: Avignon
country: France
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city: Bayonne
country: France
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city: Caen Cedex 5
country: France
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city: Clermont Ferrand
country: France
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city: Limoges
country: France
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city: Lyon
country: France
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country: France
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country: France
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city: Nice
country: France
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city: Paris
country: France
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city: Reims Cedex
country: France
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city: Saint Herblain
country: France
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city: Toulouse
country: France
facility: Research Site
city: Vandoeuvre les Nancy
country: France
facility: Research Site
city: Villejuif Cedex
country: France
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city: Augsburg
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
facility: Research Site
city: Dessau-Roßlau
country: Germany
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city: Dresden
country: Germany
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city: Erlangen
country: Germany
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city: Essen
country: Germany
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city: Esslingen am Neckar
country: Germany
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city: Frankfurt am Main
country: Germany
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city: Freiburg
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Heidelberg
country: Germany
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city: Kiel
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Trier
country: Germany
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country: Germany
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country: Hong Kong
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city: Kwai Chung
country: Hong Kong
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country: Hungary
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country: Hungary
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country: India
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country: India
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country: India
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country: India
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country: India
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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city: Okayama
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Poland
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city: Bydgoszcz
country: Poland
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city: Gdańsk
country: Poland
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city: Gdynia
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Tomaszów Mazowiecki
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Hospitalet deLlobregat
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Baden
country: Switzerland
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Frauenfeld
country: Switzerland
facility: Research Site
city: Rennaz
country: Switzerland
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Dusit
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Songkhla
country: Thailand
facility: Research Site
city: Adapazari
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: Lancaster
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Taunton
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh city
country: Vietnam
facility: Research Site
city: Vinh
country: Vietnam
facility: Research Site
Study officials:
References: