Breast CancerPhase 2NCT00468715
Bicalutamide in Treating Patients With Metastatic Breast Cancer
A Phase 2 study testing bicalutamide, diagnostic laboratory biomarker analysis and immunohistochemistry staining method in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- bicalutamide, diagnostic laboratory biomarker analysis and immunohistochemistry staining method
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Mar 2007to 24 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Duke Cancer Institute
Durham, North Carolina, 27710
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, 10035
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- bicalutamide, diagnostic laboratory biomarker analysis, immunohistochemistry staining method
- Keywords
- stage IV breast cancer, recurrent breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicalutamideDrug
diagnostic laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| bicalutamide | Experimental | 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. Receives: Drug: bicalutamide; Other: diagnostic laboratory biomarker analysis; Other: immunohistochemistry staining method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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
Measured: 1 year
Number of Participants Evaluated for Toxicity
Toxicity measured by CTCAE v3.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study start23 Mar 2007
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Tiffany A. Traina, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468715
- Sponsor's protocol ID
- 07-022
- Other IDs
- MSKCC-07022
- Status last verified
- Jun 2021
- First submitted
- 2 May 2007
- Last updated
- 3 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00468715
- Acronym / sponsor ID
- 07-022
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, male breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), AstraZeneca
- Study start
- 23 Mar 2007 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 3 May 2007 (estimated)
- Results
- Posted 3 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bicalutamide | Experimental | Drug: bicalutamide, Other: diagnostic laboratory biomarker analysis, Other: immunohistochemistry staining methodThis 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bicalutamide | Drug | bicalutamide |
| diagnostic laboratory biomarker analysis | Other | bicalutamide |
| immunohistochemistry staining method | Other | bicalutamide |
Primary outcome
6-month Response Rate (Complete Response, Partial Response, and Stable Disease)
Time frame: 6 months
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.
2 secondary outcomes
Count of Participants With Progression-free Survival
Time frame: 1 year
Number of Participants Evaluated for Toxicity
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany A. Traina, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bicalutamide, diagnostic laboratory biomarker analysis and immunohistochemistry staining method in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month Response Rate (Complete Response, Partial Response, and Stable Disease) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.