Phase 2
N=24
Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer
Invasive Breast Carcinoma · Stage I Breast Cancer AJCC v7 · Stage IA Breast Cancer AJCC v7 · Stage IB Breast Cancer AJCC v7 · Stage II Breast Cancer AJCC v6 and v7
Bottom Line
View on ClinicalTrials.gov: NCT02689427 ↗Enrolled (actual)
24
Serious AEs
12.5%
Results posted
Sep 2024
Primary outcome: Primary: RCB Status — 4; 6; 8; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Axillary Lymph Node Dissection (Procedure); Enzalutamide (Drug); Laboratory Biomarker Analysis (Other); Lymph Node Biopsy (Procedure); Paclitaxel (Drug); Therapeutic Conventional Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RCB Status |
4; 6; 8; 6 | — |
Summary
This phase IIB trial studies how well enzalutamide and paclitaxel before surgery works in treating patients with stage I-III androgen receptor-positive triple-negative breast cancer. Androgens can cause the growth of triple-negative breast cancer. Anti-hormone therapy, such as enzalutamide, prevent androgen from binding to the androgen receptor, thereby decreasing cell growth and causing tumor cell death. Drugs used in chemotherapy, such as paclitaxel, 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. Giving enzalutamide and paclitaxel before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This treatment study is part of the MD Anderson Moonshot initiative.
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent
- Patients with histologically confirmed intact primary cancer that is confirmed invasive carcinoma of the breast, with at least 1.0 cm residual disease as measured by mammography, ultrasound, or breast MRI after neoadjuvant anthracycline based chemotherapy.
- Triple-negative breast cancer defined as ER 10% of nuclear staining.
- AJCC 7th edition stage I-III Breast Cancer
- Men or women 18 years of age or older.
- Patients must have a performance status of (0-1) on the ECOG performance scale
- Negative serum or urine pregnancy test must be done within 72 hours before the first dose of the study medication for women of childbearing potential as per institutional guidelines. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy test.
- Men on study must use a condom if having sex with a pregnant woman.
- Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
- Patient must have adequate organ function as determined by the following laboratory values:
- Absolute neutrophil count ≥ 1,500 /μL
- Platelets ≥ 100,000 / μL
- Hemoglobin ≥ 9 g/dL
- Creatinine Clearance > 50 ml/min
- Total Bilirubin class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
Data sourced from ClinicalTrials.gov (NCT02689427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.