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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2022
  • participants needed
    414
  • sponsor
    Hebei Medical University Fourth Hospital
Updated on 23 January 2021
paclitaxel
cancer
combinations
estrogen
measurable disease
breast cancer
progesterone
metastasis
neutrophil count
carboplatin
capecitabine
HER2
progesterone receptor
estrogen receptor
triple-negative breast cancer

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.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Nab-paclitaxel, Nab-paclitaxel, nab paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation
Treatment Nab-paclitaxel + Carboplatin, Nab-paclitaxel + Capecitabine
Clinical Study IdentifierNCT04159142
SponsorHebei Medical University Fourth Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Females with age between 18 to 70 years old
Histologically confirmed triple negative breast cancer
No more than one-line prior treatment for locally advanced or metastatic breast cancer
Have at least one measurable lesion as per the RECIST criteria (version 1.1)
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one
Patients with life expectancy of at least 3 months
Bone marrow functionneutrophils (1.510^9/L), platelets (10010^9/L), hemoglobin (90 g/L)
Renal and hepatic function: Serum creatinine 1.5institutional upper limit of normal (ULN); AST and ALT 2.5 ULN; Total bilirubin1.5ULN, or patients with Gilbert's syndrome 2.5 ULN
Patients had good compliance with the planned treatment, understood the research process and written informed consent

Exclusion Criteria

Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores
Brain metastasis
Recurrence or metastasis within 6 months after capecitabine withdrawal
Recurrence or metastasis within 6 months after platinum withdrawal
Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months
Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding
Patients who had Grade 2 or above Peripheral neuropathy
Patients with severe systemic infection or other serious diseases
Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants
Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial
Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given
The researchers considered the patients who were not suitable for enrollment
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