New combo shows promise for aggressive breast cancer
NCT ID NCT02689427
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a combination of enzalutamide (a hormone blocker) and paclitaxel (chemotherapy) given before surgery to 24 people with a specific type of triple-negative breast cancer that has androgen receptors. The goal was to see if this treatment could shrink tumors and reduce the amount of tissue needing removal. The trial is complete, and results will help guide future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Enzalutamide and paclitaxel
- What this could lead to
- If successful, this combination could offer a new treatment option for a hard-to-treat breast cancer type, potentially shrinking tumors before surgery and improving outcomes.
- What could go wrong
- This is a small, early-phase study with only 24 participants. Results may not apply to all patients, and side effects from chemotherapy and hormone therapy are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
24 people
The number who actually took part.
- Started
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Sep 2016
- Finished
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Nov 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed written informed consent 2. 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. 3. Triple-negative breast cancer defined as ER\<10%; PR\<10% by immunohistochemistry (IHC) and HER2 0-1+ by IHC, or 2+ FISH non-amplified. 4. Androgen Receptor will be quantified using CLIA-compliant assays for AR on a biopsy specimen obtained prior to initiation of treatment.. AR-positivity is defined as \> 10% of nuclear staining. 5. AJCC 7th edition stage I-III Breast Cancer 6. Men or women 18 years of age or older. 7. Patients must have a performance status of (0-1) on the ECOG performance scale 8. 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. 9. Men on study must use a condom if having sex with a pregnant woman. 10. 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 11. 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 \< 1.5 x ULN * ALT/AST \< 2.5 x ULN Exclusion Criteria: 1. Patients who have received any previous antitumor therapies (other than anthracyclinebased neoadjuvant chemotherapy for the current cancer event). 2. Female patients must not be breast-feeding at screening or planning to become pregnant during the course of therapy. 3. Patients having major surgery within 21 days before Cycle 1, Day 1. 4. Patients with known history of hypersensitivity to paclitaxel that did not resolve with pre- medication. 5. Patients with left ventricular ejection fraction \<50% or 10% decrease from baseline on echocardiogram after anthracycline based chemotherapy. 6. Patients with gastrointestinal impairment that would affect the absorption of Enzalutamide; or previous history of colitis. 7. Subjects requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy. 8. Patients with known or suspected brain metastasis or active leptomeningeal disease. 9. History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit. 10. Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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MD Anderson West Houston
Houston, Texas, 77079, United States
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Other studies related to the condition(s) this trial covers.
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