Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2026-11-30

Brief Summary

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To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

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Detailed Description

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Triple-negative breast cancer is named because of lack of expression of estrogen receptor, progesterone receptor, and proto-oncogene HER2. This type of breast cancer is highly heterogeneous, is more likely to recur locally and develop distant metastasis, and has high invasiveness and low survival rate. Because both endocrine therapy and targeted therapy are ineffective for triple-negative breast cancer, so the main currently available treatment is chemotherapy. Some patients may choose anti-angiogenic therapy. The prognosis of triple-negative breast cancer is worse than that of other types of breast cancer due to fewer treatment options. Guidelines and Specifications for Diagnosis and Treatment of Breast Cancer (2017 edition) compiled by Committee of Breast Cancer Society of Chinese Anti-Cancer Association suggest that neoadjuvant therapy should be recommended for patients with large-sized tumors (maximum diameter greater than 5 cm), axillary lymph node metastasis, human epidermal growth factor receptor 2 (HER-2) positive, triple-negative breast cancer, and breast-conserving intention. The guidelines also suggest that neoadjuvant therapy for triple-negative breast cancer should apply anthracyclines and taxanes. Guidelines of Chinese Society of Clinical Oncology (CSCO) Breast Cancer 2018.V1 propose that the treatment regimen of triple-negative breast cancer should apply anthracyclines and taxanes. The treatment regimens of taxanes, anthracyclines, and cyclophosphamides in combination (1A) or taxanes combined with anthracyclines (2A) are strongly recommended. In 2015, St Gallen recommended anthracyclines and taxanes as the main chemotherapeutic drugs for triple-negative breast cancer. However, the pathologic complete remission (pCR) rate of paclitaxel combined with anthracycline as neoadjuvant therapy was still less than 50%. In the GALGB40603 study, the pCR rate of breast and axillary lymph nodes increased from 41% to 54% with carboplatin based on standard chemotherapeutic drugs anthracycline combined with taxanes. The Gepar Sixto-GBG 66 study also suggested that carboplatin could increase the pCR rate in triple-negative breast cancer patients. Compared with other dosage forms of paclitaxel, albumin-bound paclitaxel can produce higher paclitaxel concentration in local tumors, and the injection time is shorter. At present, the drug has been approved by the Food and Drug Administration of the United States for adjuvant chemotherapy for breast cancer with metastasis or recurrence within 6 months that fails to respond to combined chemotherapy. However, little is currently reported on albumin-bound paclitaxel combined with carboplatin versus anthracycline combined with paclitaxel in China. A multicenter randomized controlled phase IV clinical trial will be conducted to investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Trial group

55 cases of triple-negative breast cancer will be assigned into a trial group.

Group Type EXPERIMENTAL

Albumin-bound paclitaxel combined with carboplatin

Intervention Type DRUG

Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel (Abraxis BioScience, LLC., Mclrose Park, IL, USA; certificate number: H20091059) will be intravenously administered at 125 mg/m2 for 30 minutes on days 1 and 8 of each 21-day session of treatment. There will be six 21-day sessions of treatment. At the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; National Drug Approval Number: H20020181) will be intravenously administered at AUC = 2 mg•min/mL for 120 minutes on days 1 and 8 of each 21-day session of treatment. Carboplatin must be hydrated for 3 days before use to prevent nephrotoxicity.

Control group

55 cases of triple-negative breast cancer will be assigned into a control group.

Group Type ACTIVE_COMPARATOR

Epirubicin combined with docetaxel

Intervention Type DRUG

Epirubicin (Pfizer Pharmaceutical (Wuxi) Co., Ltd., China; National Drug Approval Number: H20000496) will be intravenously administered at 90 mg/m2 for 120 minutes on day 1 of each 21-day session of treatment. At the same time, docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; National Drug Approval Number: J20150083) will be intravenously administered at 75 mg/m2 for 120 minutes. Drug administration will be performed once every other 3 weeks for four times.

Interventions

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Albumin-bound paclitaxel combined with carboplatin

Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel (Abraxis BioScience, LLC., Mclrose Park, IL, USA; certificate number: H20091059) will be intravenously administered at 125 mg/m2 for 30 minutes on days 1 and 8 of each 21-day session of treatment. There will be six 21-day sessions of treatment. At the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; National Drug Approval Number: H20020181) will be intravenously administered at AUC = 2 mg•min/mL for 120 minutes on days 1 and 8 of each 21-day session of treatment. Carboplatin must be hydrated for 3 days before use to prevent nephrotoxicity.

Intervention Type DRUG

Epirubicin combined with docetaxel

Epirubicin (Pfizer Pharmaceutical (Wuxi) Co., Ltd., China; National Drug Approval Number: H20000496) will be intravenously administered at 90 mg/m2 for 120 minutes on day 1 of each 21-day session of treatment. At the same time, docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; National Drug Approval Number: J20150083) will be intravenously administered at 75 mg/m2 for 120 minutes. Drug administration will be performed once every other 3 weeks for four times.

Intervention Type DRUG

Other Intervention Names

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Albumin-bound paclitaxel+carboplatin group Epirubicin+docetaxel group

Eligibility Criteria

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Inclusion Criteria

* patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III;
* estimated survival \> 3 months;
* presence of clinically measurable lesions;
* Karnofsky functional status score ≥ 70;
* normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations;
* age at 18-70 years.

Exclusion Criteria

* stage IV breast cancer patients with bone metastasis or other distant metastasis;
* severe renal insufficiency;
* older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy;
* those who have received antineoplastic therapy;
* those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy;
* those with history of other malignant tumors;
* those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens;
* those with mental and nervous system diseases who cannot comply with treatment;
* those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy;
* pregnant or lactating women;
* those who are participating in other trials.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No