Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer (SYSUCC-007)
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ClinicalTrials.gov Identifier: NCT03055312 |
Recruitment Status :
Terminated
First Posted : February 16, 2017
Last Update Posted : January 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Triple Negative Breast Cancer | Drug: TPC Drug: Bicalutamide 150 mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer |
Actual Study Start Date : | December 20, 2016 |
Actual Primary Completion Date : | November 15, 2020 |
Actual Study Completion Date : | November 15, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: TPC chemotherapy
Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin) |
Drug: TPC
Conventional chemotherapy(choose a): TX:(Docetaxel 75mg/m2 iv day1 and Capecitabine 950mg/m2 po twice daily days 1-14)every 3 weeks. GT:(Paclitaxel 175mg/m2 iv day1 and Gemcitabine 1250mg/m2 iv days 1 & days 8)every 3 weeks. GC:(Gemcitabine 1000mg/m2 on days 1 & days 8 and Carboplatin by Area Under Curve (AUC) 2 iv on days 1 & days 8) every 3 weeks Other Name: Chemotherapy |
Experimental: Bicalutamide
Bicalutamide 150mg/day every 28 days
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Drug: Bicalutamide 150 mg
Bicalutamide 150mg/day,every 28 days
Other Name: Bicalutamide |
- Clinical benefit rate for 16 weeks [ Time Frame: 16 weeks ]The proportion of patients with complete response, partial response and stable disease
- progression-free survival [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 18-70 years old, female
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Confirmed by pathology or organizing cytology AR positive(IHC:≧10%)triple negative breast cancer
- For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
- Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
- After Recurrence has not received cancer treatment
- Life expectancy of at least 6 months
- Signed and dated an informed consent form
Exclusion Criteria:
- ECOG score ≧2
- Only brain metastasis or meningeal metastasis
- Receiving other anti-tumor treatment
- Heart,lung,liver,kidney,bone marrow,and other functions badness

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055312
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 | |
Sun Yat-sen University, Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Zhong-Yu Yuan, M.D | Sun Yat-sen University |
Responsible Party: | Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT03055312 |
Other Study ID Numbers: |
SYSUCC-007 |
First Posted: | February 16, 2017 Key Record Dates |
Last Update Posted: | January 28, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Bicalutamide Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents |