Breast Cancer Clinical Trial
Official title:
Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 10, 2024 |
Est. primary completion date | September 10, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Nigeria | University College Hospital, Ibadan, Nigeria | Ibadan |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure the complete pathologic response (pCR) | Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders. | 4-6 months | |
Secondary | Number of participants with adverse events | Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions. | 4-6 months | |
Secondary | Time until progression free survival (PFS) | 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 | ||
Secondary | Duration of response (DOR) | From first reponse to the date of first documented disease progression or death, assessed up to 10 years | ||
Secondary | Analysis of changes from baseline using the quality of life (QoL) instrument: EORTC | The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module). | 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 | |
Secondary | Blood concentrations of Herceptin SC given in combination with Docetaxel | Blood concentrations of Herceptin SC at multiple time points using the peak exposure | 21 days | |
Secondary | Drug plasma concentration of Herceptin SC given in combination with FEC | Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH | 21 days | |
Secondary | The cardiac toxicity associated with TscH with FEC +scH in breast cancer patients | The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%. | Through study completion an average of two years | |
Secondary | The cardiac toxicity associated with TscH without FEC +scH in breast cancer patients | The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%. | Through study completion an average of two years |
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