A multicenter, randomized, controlled, open phase II study for comparing the efficacy and safety of albumin paclitaxel plus bicalutamide and albumin paclitaxel in the treatment of androgen receptor-positive advanced triple-negative breast cancer

Comparison of the efficacy and safety of albumin paclitaxel combined with bicalutamide and albumin paclitaxel in the treatment of androgen receptor-positive advanced triple-negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021220

Enrollment

Unknown

Registered

2019-02-01

Start date

2019-01-31

Completion date

Unknown

Last updated

2019-02-04

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

Conditions

Breast cancer

Interventions

Group 1:Bicalutamide + Albumin Paclitaxel

Group 2:Albumin Paclitaxel

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis of women with advanced breast cancer over 18 years of age; 2. Have not received chemotherapy or targeted therapy for advanced breast cancer; 3. Pathological examination confirmed ER and / or PR negative, HER2 negative advanced breast cancer patients (positive ER expression: refers to immunohistochemistry 10% strong staining of tumor cells; 5. Having at least one evaluable lesion judged according to the RECIST criteria; 6. ECOG physical score of 0-1, expected survival of not less than 3 months; 7. The main organs function normally, that is, meet the following criteria: Blood function: neutrophil count (ANC) = 1.5 × 10 ^ 9 / L, platelet count (PLT) = 75 × 10 ^ 9 / L; hemoglobin > 90g / L; Liver function: total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase (ALT / AST) = 2.5 × ULN (liver metastasis patients = 5xULN); Renal function: serum creatinine = 1.5 × ULN or creatinine clearance (Ccr) = 60 ml / min; 8. Informed consent has been signed prior to enrollment; 9. Have good compliance.

Exclusion criteria

Exclusion criteria: Any of the following items cannot be grouped: 1. Previously received systemic treatment for advanced breast cancer; 2. Only central nervous system metastasis (including brain parenchyma, pia mater and meningeal metastasis); 3. Any serious underlying diseases, comorbidities and infections 4. Receiving other anti-tumor treatments; 5. History of epilepsy or status of epilepsy; 6. Pregnant or breast-feeding patients; 7. Those with poor compliance or unable to perform normal follow-up; 8. It is suspected that it may be allergic to drugs; 9. Symptomatic heart disease; 10. Unable to swallow the drug; 11. Other malignant tumors diagnosed within 5 years.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Secondary

Measure	Time frame
Overall Survival;Objective Response Rate;	—

Countries

China

Contacts

Public ContactHerui Yao

Sun Yat-sen Memorial Hospital Sun Yat-sen University

yaoherui@163.com+86 020 34070412

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026