Clinical trial NCT04136782: Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer
Official title: Albumin-bound Paclitaxel Combined With Carboplatin Versus Epirubicin Combined With Docetaxel as Neoadjuvant Therapy for Triple-negative Breast Cancer: a Multicenter Randomized Controlled Phase IV Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Keywords: adjuvant chemotherapy
paclitaxel
albumin-bound paclitaxel
carboplatin
docetaxel
epirubicin
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 110
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: To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pathologic complete remission rate
timeFrame: 5 years after treatment
Secondary outcomes:
measure: Breast-conserving rate
timeFrame: After 6 months of treatment
measure: Incidence of osteoporosis
timeFrame: Every 6 months for 5 successive years
measure: Incidence of bone-related events
timeFrame: Every 6 months for 5 successive years
measure: Incidence of other distant organ metastasis related events
timeFrame: Every 6 months for 5 successive years
measure: Disease-free survival (DFS)
timeFrame: Within 5 years after disease onset.
measure: Overall survival (OS)
timeFrame: Within 5 years after disease onset.
measure: Adverse events
timeFrame: in 5 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: Cancer Hospital Affiliated to Harbin Medical University
state: Heilongjiang
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Panjin
country: China
facility: Panjin Liaohe Oilfield Gem Flower Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Caigang Liu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: