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

Triple Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159142
• Other study ID #: CSPC-KAL-BC-16
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2019
• Est. completion date: September 20, 2022

Study information

• Verified date: November 2019
• Source: Hebei Medical University Fourth Hospital
• Contact: Cuizhi Geng, M.D.
• Phone: 0311-6669 6310
• Email: gengcuizhi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: September 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Nab-paclitaxel
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• 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;
• 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;

Locations

Country	Name	City	State
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (3)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital	CSPC Ouyi Pharmaceutical Co., Ltd., The fifth medical center of PLA general hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Up to disease progression or death due to any cause	3 years
Secondary	PFS rate for 6 cycles	From the date of randomization to the end of 6 cycles	At the end of Cycle 6 (each cycle is 21 days)
Secondary	Objective response rate (ORR)	To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer	3 years
Secondary	Overall survival (OS)	To evaluate the overall survival of patients with advanced triple-negative breast cancer	3 years
Secondary	Adverse events (AE)	To evaluate the adverse events of patients with advanced triple-negative breast cancer	3 years