Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Enzalutamide 160mg Obynx + Chemotherapy: Chemotherapy includes (Capecitabine, Paclitaxel / Nab-paclitaxel, Gemcitabine, Eribulin)
Enzalutamide is initiated on Day 1 of chemotherapy and
Sponsors
Zydus Lifesciences
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must have histologically or cytologically confirmed invasive breast carcinoma. Disease must be locally advanced unresectable or metastatic breast cancer. Tumor must be triple negative breast cancer defined as estrogen receptor and progesterone receptor less than one percent by immunohistochemistry and HER2 negative defined as HER2 IHC 0 or 1 plus or IHC 2 plus with FISH negative. Tumor must be androgen receptor positive defined as androgen receptor expression greater than or equal to ten percent by immunohistochemistry. Subjects must be chemotherapy naive for the advanced or metastatic setting. Eastern Cooperative Oncology Group performance status must be zero to two. Subjects must have adequate hematologic hepatic renal and pulmonary function as defined in the protocol. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during treatment and for the protocol specified period after treatment. Male subjects with partners of childbearing potential must agree to use effective contraception during treatment and for the protocol specified period after treatment. Subjects must be able to understand and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Subjects receiving any other concurrent investigational agents are excluded. Subjects previously exposed to anti androgen therapy after the diagnosis of breast cancer are excluded. Subjects with symptomatic brain metastases or brain metastases requiring active treatment are excluded. Subjects with active infection requiring systemic therapy are excluded. Subjects with hepatitis B virus infection with positive surface antigen and elevated HBV DNA or hepatitis C virus infection with positive anti HCV antibody and elevated HCV RNA are excluded. Subjects with known severe hypersensitivity to the investigational product or any component of its formulation are excluded. Subjects with clinically significant active cardiovascular disease including unstable angina congestive heart failure New York Heart Association class two or higher serious uncontrolled cardiac arrhythmia or asymptomatic individuals with left ventricular ejection fraction less than fifty percent are excluded. Subjects with other severe acute or chronic medical conditions including inflammatory bowel disease pneumonitis chronic kidney disease chronic liver disease pulmonary fibrosis known peripheral neuropathy greater than grade one as per CTCAE version five or significant psychiatric illness including recent or active suicidal ideation or behavior are excluded. Pregnant women are excluded from the study. Subjects with any other concomitant malignancy within the last five years except adequately treated basal cell carcinoma squamous cell carcinoma of the skin or carcinoma in situ of the cervix are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II Primary Outcome: Progression Free Survival defined as the time from the date of randomization to the date of documented disease progression as per RECIST version 1.1 or death from any cause whichever occurs first. Phase III Primary Outcome: Overall Survival defined as the time from the date of randomization to death from any cause or last follow up for surviving patients.Timepoint: Baseline and every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) Clinical Benefit Rate (CBR) Safety and Tolerability Quality of Life (QOL)Timepoint: ORR and CBR assessed every 12 weeks from randomization | — |
Countries
India
Contacts
Public ContactDr Sushmita Rath
Tata Memorial Hospital
Outcome results
None listed