Clinical trial NCT04159142: Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Official title: Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Nab-paclitaxel
Keywords: Nab-paclitaxel
Carboplatin
Capecitabine
Triple Negative Breast Cancer
Maintenance therapy
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2019-11-12
Enrollment: 414
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: PFS rate for 6 cycles
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
measure: Objective response rate (ORR)
timeFrame: 3 years
measure: Overall survival (OS)
timeFrame: 3 years
measure: Adverse events (AE)
timeFrame: 3 years
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Beijing 302 Hospital
name: Zefei Jiang, M.D.
role: STUDY_CHAIR
affiliation: Hebei Medical University Fourth Hospital
name: Cuizhi Geng, M.D.
role: STUDY_CHAIR
References: