This phase II trial studies the effect of docetaxel and trastuzumab before surgery in treating HER2 positive stage II-III breast cancer in Nigerian women. Chemotherapy drugs, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. This study is being done to determine how effective and safe docetaxel and trastuzumab are before surgery in Nigerian women with breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03879577.
PRIMARY OBJECTIVES:
I. To determine the efficacy of docetaxel + trastuzumab (Herceptin) subcutaneous (SC) every three weeks for four cycles with or without fluorouracil, epirubicin, and cyclophosphamide (FEC) + Herceptin SC for three cycles (with tamoxifen/letrozole added to estrogen receptor [ER]/progesterone receptor [PR] Positive patients) in Nigerian women with HER2-positive breast cancer.
II. To determine the toxicity of every three-weeks docetaxel + SC Herceptin with or without FEC + Herceptin SC for three cycles (with tamoxifen/letrozole added to ER/PR Positive patients) in Nigerian women with HER2- positive breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate other response-related endpoints: duration of response (DOR), clinical response, progressive disease during neoadjuvant treatment, breast-conserving surgery, invasive disease-free survival.
II. To determine the cardiac toxicity associated with SC Herceptin (TscH) with or without FEC +scH in breast cancer patients.
III. To determine the pharmacokinetic profile of Herceptin SC given in combination with docetaxel.
IV. To determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to trastuzumab (TH).
V. To evaluate the quality of life (QoL) of patients on every three-weeks docetaxel (+ FEC) with Herceptin over time.
VI. To explore mechanisms of resistance to HER2 targeted therapy in Nigerian women.
OUTLINE:
Patients receive trastuzumab subcutaneously (SC) over 2-5 minutes on day 1. Treatment with trastuzumab repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Pre-menopausal and hormone receptor positive patients also receive goserelin acetate SC every 3 months for 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel intravenously (IV) over 1 hour on day 1. Treatment docetaxel repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4 weeks of completion of docetaxel, patients with complete clinical response (CCR) undergo surgery. Patients with partial response or stable disease receive fluorouracil IV, epirubicin IV over 1 hour, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of surgery, hormone receptors positive patients also receive tamoxifen orally (PO) daily or letrozole PO daily for 10 years in the absence of disease of progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 60 days, every 3 months for 2 years, and then every 6 months for up to 10 years.
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorOlufunmilayo Falusi Olopade
