Breast CancerPhase 2NCT02348281
Bicalutamide as A Treatment in AR-positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients
A Phase 2 study testing Bicalutamide in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This prospective, single center, phase II study is to evaluate the efficacy and safety of bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative breast cancer (mTNBC) patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bicalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females elder than 18
- Histological proven unresectable or metastatic breast cancer patients who underwent at least one chemotherapy regimen for metastatic disease
- Patients with androgen Receptor (AR) positive (IHC >10% nuclear staining) either for primary tumor or metastatic lesion
- Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by IHC (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
- Performance status no more than 2
Show all 11Show fewer
- All patients enrolled are required to have adequate hematologic, hepatic, and renal function
- Life expectancy longer than 12 weeks
- No serious medical history of heart, lung, liver and kidney
- Be able to understand the study procedures and sign informed consent.
- Patients with good compliance
Who cannot join
- Pregnant or lactating women
- Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
- Patients treated with an investigational product within 4 weeks before the enrollment
- Patients who received chemotherapy within 4 weeks before the enrollment
- Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
- Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
- Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
- Uncontrolled serious infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Center, Phase II Study of Bicalutamide as A Treatment in Androgen Receptor (AR)-Positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients
This prospective, single center, phase II study is to evaluate the efficacy and safety of bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative breast cancer (mTNBC) patients.
Read the detailed description
Triple-negative breast cancer (TNBC) is defined as the absence of estrogen and progesterone receptor expression as well as ERBB2 amplification. It has no response to endocrine or anti-ERBB2 therapies. Recent studies have found some potential therapeutic targets for TNBC. However, it still has a poor outcome. It was reported that TNBC has six subtypes, including 2 basal-like (BL1 and BL2), an immunomodulatory (IM), a mesenchymal (M), a mesenchymal stem-like (MSL), and a luminal androgen receptor (LAR) subtype. Different subtype may be sensitive to different treatment. Bicalutamide is an oral, non-steroidal, androgen receptor (AR) antagonist. It is approved by the Food and Drug Administration (FDA) for the treatment of metastatic prostate cancer. Recently, a study explored the efficacy of bicalutamide in AR positive, estrogen receptor negative metastatic breast cancer (MBC), which showed a high clinical benefit rate (CBR) and a good safety profile. Based on the above reasons, we initiate this phase II study to evaluate the efficacy and safety of bicalutamide in AR positive metastatic triple-negative breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Bicalutamide
- Keywords
- triple negative breast cancer, androgen receptor, bicalutamide
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Casodex
150mg, po, qd, d1-28
| Study group | Role | What they receive |
|---|---|---|
| bicalutamide | Experimental | 150mg, po, qd, d1-28 Receives: Drug: Bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate (CBR)
Clinical benefit rate is defined as the percentage of patients who achieve complete response (CR), partial response (PR) and stable disease (SD) ≥24 weeks by RECIST version 1.1 criteria.
Measured: every 8 weeks, up to 48 weeks
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate is defined as the percentage of patients who achieve complete response (CR) and partial response (PR) by RECIST version 1.1 criteria.
Measured: every 8 weeks, up to 24 weeks
Progression free survival (PFS)
Progression free survival is defined as the time from enrollment to the first documented disease progression or death from any cause.
Measured: every 8 weeks, up to 48 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Evaluate incidence of adverse events and severity grade of these events
Measured: every 4 weeks, up to 24 weeks
Overall Survival (OS)
Overall Survival is defined as the time from enrollment to death from any cause.
Measured: every 3 months, up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: it's too slow to enroll suitable patients into this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, M.D., Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348281
- Sponsor's protocol ID
- Fudan BR2015-17
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Phase II Study of Bicalutamide as A Treatment in Androgen Receptor (AR)-Positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients
- ClinicalTrials.gov ID
- NCT02348281
- Acronym / sponsor ID
- Fudan BR2015-17
- Conditions
- Breast Cancer
- Keywords
- triple negative breast cancer, androgen receptor, bicalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: it's too slow to enroll suitable patients into this study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single center, phase II study is to evaluate the efficacy and safety of bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative breast cancer (mTNBC) patients.
Detailed description
Triple-negative breast cancer (TNBC) is defined as the absence of estrogen and progesterone receptor expression as well as ERBB2 amplification. It has no response to endocrine or anti-ERBB2 therapies. Recent studies have found some potential therapeutic targets for TNBC. However, it still has a poor outcome. It was reported that TNBC has six subtypes, including 2 basal-like (BL1 and BL2), an immunomodulatory (IM), a mesenchymal (M), a mesenchymal stem-like (MSL), and a luminal androgen receptor (LAR) subtype. Different subtype may be sensitive to different treatment. Bicalutamide is an oral, non-steroidal, androgen receptor (AR) antagonist. It is approved by the Food and Drug Administration (FDA) for the treatment of metastatic prostate cancer. Recently, a study explored the efficacy of bicalutamide in AR positive, estrogen receptor negative metastatic breast cancer (MBC), which showed a high clinical benefit rate (CBR) and a good safety profile. Based on the above reasons, we initiate this phase II study to evaluate the efficacy and safety of bicalutamide in AR positive metastatic triple-negative breast cancer patients.
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: Bicalutamide150mg, po, qd, d1-28 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Females elder than 18
- Histological proven unresectable or metastatic breast cancer patients who underwent at least one chemotherapy regimen for metastatic disease
- Patients with androgen Receptor (AR) positive (IHC >10% nuclear staining) either for primary tumor or metastatic lesion
- Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by IHC (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
- Patients treated with an investigational product within 4 weeks before the enrollment
- Patients who received chemotherapy within 4 weeks before the enrollment
- Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
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 |
|---|---|---|
| BicalutamideAlso: Casodex150mg, po, qd, d1-28 | Drug | bicalutamide |
Primary outcome
Clinical benefit rate (CBR)
Time frame: every 8 weeks, up to 48 weeks
Clinical benefit rate is defined as the percentage of patients who achieve complete response (CR), partial response (PR) and stable disease (SD) ≥24 weeks by RECIST version 1.1 criteria.
4 secondary outcomes
Objective response rate (ORR)
Time frame: every 8 weeks, up to 24 weeks
Progression free survival (PFS)
Time frame: every 8 weeks, up to 48 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: every 4 weeks, up to 24 weeks
Overall Survival (OS)
Time frame: every 3 months, up to 100 months
Results and safety
The study was stopped early (reason given: it's too slow to enroll suitable patients into this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
Xichun Hu, M.D., Ph.D. principal investigator
Fudan University
1 site 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 in people with Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study was stopped early (reason given: it's too slow to enroll suitable patients into this study). Results are not available in the source record.
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?
Clinical benefit rate (CBR) (time frame: every 8 weeks, up to 48 weeks). 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 23 Jan 2018.