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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00468715
Enrollment
28
Registered
2007-05-03
Start date
2007-03-23
Completion date
2021-06-24
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer, male breast cancer

Brief summary

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.

Detailed description

OBJECTIVES: Primary * Determine the 6-month efficacy rate of bicalutamide as first-, second-, or third-line therapy in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer. Secondary * Determine the 6-month progression-free survival of patients treated with this drug. * Evaluate the safety of this drug in these patients. * Evaluate changes in estradiol, total and free testosterone, and sex-hormone binding globulin in response to androgen blockade in patients treated with this drug. * Evaluate tissue, including cytokeratins 5/6 and 17, SPDEF, ALCAM, ERBB2, FGFR4, and prostate-specific antigen (PSA), using immunohistochemical analysis in patients treated with this drug. OUTLINE: This is a open-label study. Patients receive oral bicalutamide once daily for 4 weeks. Treatment repeats every 4 weeks for 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue to receive bicalutamide as above at the discretion of the investigator. Patients undergo blood and tissue sample collection for correlative studies. Samples are analyzed for hormonal levels, including estradiol, total testosterone, free testosterone, and sex-hormone binding globulin, and proteins, including ALCAM, SPEDF, and CK 5/6, by immunohistochemical analysis at baseline, after course 1, and at the end of the study. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Interventions

DRUGbicalutamide
OTHERdiagnostic laboratory biomarker analysis
OTHERimmunohistochemistry staining method

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
AstraZeneca
CollaboratorINDUSTRY
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
6-month Response Rate (Complete Response, Partial Response, and Stable Disease)6 monthsPer 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

MeasureTime frameDescription
Count of Participants With Progression-free Survival1 yearProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Number of Participants Evaluated for Toxicity1 yearToxicity measured by CTCAE v3.0

Countries

United States

Participant flow

Participants by arm

ArmCount
Bicalutamide
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. bicalutamide diagnostic laboratory biomarker analysis immunohistochemistry staining method
28
Total28

Baseline characteristics

CharacteristicBicalutamide
Age, Continuous54 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
26 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
5 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
22 Participants
Region of Enrollment
United States
28 Participants
Sex: Female, Male
Female
28 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
14 / 28
other
Total, other adverse events
28 / 28
serious
Total, serious adverse events
4 / 28

Outcome results

Primary

6-month Response Rate (Complete Response, Partial Response, and Stable Disease)

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.

Time frame: 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Bicalutamide6-month Response Rate (Complete Response, Partial Response, and Stable Disease)Stable Disease9 Participants
Bicalutamide6-month Response Rate (Complete Response, Partial Response, and Stable Disease)Progression of Disease15 Participants
Bicalutamide6-month Response Rate (Complete Response, Partial Response, and Stable Disease)Not Entered4 Participants
Secondary

Count of Participants With Progression-free Survival

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Time frame: 1 year

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
BicalutamideCount of Participants With Progression-free SurvivalParticipants who progressed22 Participants
BicalutamideCount of Participants With Progression-free SurvivalParticipants who did not progress6 Participants
Secondary

Number of Participants Evaluated for Toxicity

Toxicity measured by CTCAE v3.0

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BicalutamideNumber of Participants Evaluated for Toxicity28 Participants

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026