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

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

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.

Study Overview

• Status: Unknown
• Conditions: Triple Negative Breast Cancer; Nab-paclitaxel
• Intervention / Treatment: Drug: Nab-paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Capecitabine

• Study Type: Interventional
• Enrollment (Anticipated): 414
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Recruiting
      • The Fourth Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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;	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；
EXPERIMENTAL: 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;	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；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Up to disease progression or death due to any cause	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Objective response rate (ORR)	To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer	3 years
Overall survival (OS)	To evaluate the overall survival of patients with advanced triple-negative breast cancer	3 years
Adverse events (AE)	To evaluate the adverse events of patients with advanced triple-negative breast cancer	3 years

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital
• Collaborators: Beijing 302 Hospital; CSPC Ouyi Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Zefei Jiang, M.D., Beijing 302 Hospital; Study Chair: Cuizhi Geng, M.D., The Fourth Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 20, 2019
• Primary Completion (ANTICIPATED): June 20, 2022
• Study Completion (ANTICIPATED): September 20, 2022

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (ACTUAL): November 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Capecitabine; Carboplatin; Triple Negative Breast Cancer; Maintenance therapy; Nab-paclitaxel
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Capecitabine; Albumin-Bound Paclitaxel
• Other Study ID Numbers: CSPC-KAL-BC-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No