Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

NCT ID: NCT04159142

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2028-09-20

Brief Summary

This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.

The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.

Conditions

Triple Negative Breast Cancer; Nab-paclitaxel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel + Carboplatin

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m\^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;

Group Type: EXPERIMENTAL

Nab-paclitaxel + Carboplatin

Intervention Type: DRUG

nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；

Nab-paclitaxel + Capecitabine

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m\^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;

Group Type: EXPERIMENTAL

Nab-paclitaxel + Capecitabine

Intervention Type: DRUG

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles；

Interventions

Nab-paclitaxel + Carboplatin

nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；

Intervention Type: DRUG

Nab-paclitaxel + Capecitabine

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles；

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Females with age between 18 to 70 years old;

2. Histologically confirmed triple negative breast cancer;

3. No more than one-line prior treatment for locally advanced or metastatic breast cancer;

4. Have at least one measurable lesion as per the RECIST criteria (version 1.1);

5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;

6. Patients with life expectancy of at least 3 months;

7. Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);

8. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;

9. Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria

1. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;

2. Brain metastasis;

3. Recurrence or metastasis within 6 months after capecitabine withdrawal;

4. Recurrence or metastasis within 6 months after platinum withdrawal;

5. Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;

6. Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;

7. Patients who had Grade 2 or above Peripheral neuropathy;

8. Patients with severe systemic infection or other serious diseases;

9. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;

10. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;

11. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;

12. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;

13. The researchers considered the patients who were not suitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cuizhi GENG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zefei Jiang, M.D.

Role: STUDY_CHAIR

Beijing 302 Hospital

Cuizhi Geng, M.D.

Role: STUDY_CHAIR

Hebei Medical University Fourth Hospital

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cuizhi Geng, M.D.

Role: CONTACT

gengcuizhi@hotmail.com

0311-6669 6310

Facility Contacts

Cuizhi Geng, M.D.

Role: primary

gengcuizhi@hotmail.com

0311-6669 6310

Other Identifiers

CSPC-KAL-BC-16

Identifier Type: -

Identifier Source: org_study_id