Clinical trial · Interventional
Bicalutamide in Treating Patients With Metastatic Breast Cancer
Bicalutamide for the Treatment of Androgen Receptor Positive (AR(+)), Estrogen Receptor Negative, Progesterone Receptor Negative (ER(-)/PR(-)) Metastatic Breast Cancer Patients: A Phase II Feasibility Study
NCT00468715CI-TRIAL-00060037completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such as bicalutamide, may stop the adrenal glands from making androgens. PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients with metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bicalutamide
- description
- This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
- interventionNames
- Drug: bicalutamide
- Other: diagnostic laboratory biomarker analysis
- Other: immunohistochemistry staining method
Primary outcomes (1)
- measure
- 6-month Response Rate (Complete Response, Partial Response, and Stable Disease)
- timeFrame
- 6 months
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Stage IV disease * Measurable or non-measurable disease * Patients with HER2/neu-positive disease must have received prior trastuzumab (Herceptin®) * No active brain metastases or leptomeningeal disease * History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain * Hormone receptor status: * Estrogen receptor- and progesterone receptor-negative\* * Androgen receptor-positive\* NOTE: \*Samples are considered positive if greater than 10% of cell nuclei are immunoreactive PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the absence of liver metastases) * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious medical or psychiatric illness * No serious active infection * No other malignancy within the past 5 years except nonmelanoma skin cancer * No hypersensitivity reaction to bicalutamide or any of the tablet's components PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior cytotoxic chemotherapy and recovered * At least 3 weeks since prior investigational drugs * At least 4 weeks since prior major surgery and recovered * Prior neoadjuvant or adjuvant chemotherapy allowed * Any number of chemotherapy regimens are allowed for metastatic disease * Prior hormonal therapy allowed * No concurrent chemotherapy, other hormonal therapy, immunotherapy, or biological therapy * No concurrent trastuzumab (Herceptin®) * No concurrent enrollment in another clinical trial in which investigational procedures are performed or investigational therapies are administered
References
Publications (0)
Data not yet available
No reference posted for this study.