Clinical trial NCT03879577: Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer
Official title: Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Breast Cancer Female
HER2-positive Breast Cancer
Breast Cancer Stage II
Breast Cancer Stage III
Keywords: breast cancer
breast cancer stage II
Breast Cancer Stage III
Docetaxel
Herceptin
neoadjuvant treatment
nigeria
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.


Eligibility criteria: Inclusion Criteria:

1. Women ages of 18 to 70 years old
2. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
3. Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
4. Clinical stages IIA -IIIC (AJCC 2009)
5. Chemotherapy-naïve patients (for this malignancy)
6. Performance status: ECOG performance status 0-1 (Appendix A)
7. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive LHRH agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
8. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:

1. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC) ≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT \< 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by CKD EPI equation (see http://mdrd.com/ for calculator)

9. ECHO: Baseline left ventricular ejection fraction of ≥ 55%

Exclusion Criteria:

1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last Herceptin administration.
2. Patients with distant metastasis (brain and/or visceral metastasis)
3. Serious, uncontrolled, concurrent infection(s).
4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
6. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.
7. Patients with HER2-negative disease

Primary outcomes:
measure: Measure the complete pathologic response (pCR)
timeFrame: 4-6 months
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 4-6 months
measure: Time until progression free survival (PFS)
timeFrame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
measure: Duration of response (DOR)
timeFrame: From first reponse to the date of first documented disease progression or death, assessed up to 10 years
measure: Analysis of changes from baseline using the quality of life (QoL) instrument: EORTC
timeFrame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
measure: Blood concentrations of Herceptin SC given in combination with Docetaxel
timeFrame: 21 days
measure: Drug plasma concentration of Herceptin SC given in combination with FEC
timeFrame: 21 days
measure: The cardiac toxicity associated with TscH with FEC +scH in breast cancer patients
timeFrame: Through study completion an average of two years
measure: The cardiac toxicity associated with TscH without FEC +scH in breast cancer patients
timeFrame: Through study completion an average of two years
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital, Ibadan, Nigeria
Study officials:
affiliation: University of Chicago
name: Olufunmilayo I Olopade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ntekim AI, Ibraheem A, Sofoluwe AA, Kotila O, Babalola C, Karrison T, Olopade CO. ARETTA: Assessing Response to Neoadjuvant Taxotere and Subcutaneous Trastuzumab in Nigerian Women With HER2-Positive Breast Cancer: A Study Protocol. JCO Glob Oncol. 2020 Jul;6:983-990. doi: 10.1200/GO.20.00043.