A Phase 4 interventional study of Docetaxel and Carboplatin in Breast Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Treatment
Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
At present, the treatment of early-stage breast cancer is mainly surgical, supplemented by chemotherapy, endocrine therapy, radiotherapy, targeted therapy and other comprehensive treatment methods, through the use of a variety of comprehensive and individualized treatment plans led to a significant improvement in the quality of life and survival of breast cancer patients. Systematic adjuvant therapy after surgery is also gaining increasing attention, with a large number of randomized clinical trials worldwide . The effectiveness of adjuvant therapy in reducing the recurrence of breast cancer and improving survival has been demonstrated in a number of randomized clinical trials worldwide. Adjuvant therapy after surgery is recommended in NCCN guidelines, ESMO, St. Gallen and other guidelines or expert consensus.
The use of albumin paclitaxel in the postoperative adjuvant treatment of breast cancer has been reported overseas, and a phase II clinical study published in 2017 investigated the tolerability and feasibility of dose dense doxorubicin combined with cyclophosphamide followed by nab-paclitaxel (AC-nP) chemotherapy in patients with high-risk early-stage breast cancer in adjuvant treatment. The results suggested that this regimen was well tolerated, with an incidence of granular deficiency with fever 5 of 2%, suggesting the safety of weekly treatment with nab-paclitaxel.
Another study evaluated the safety of dose-dense AC-nP regimens in women with high-risk breast cancer. Enrolled patients received 4 cycles of AC (every 2 weeks) followed by nab-P (every 2 weeks). The most common eventual adverse reaction was peripheral neuropathy, although approximately 80% of patients were grade 1-2, and the patient's neuropathy gradually improved after the end of treatment. This suggests that in early breast cancer, the use of dose-dense AC followed by nab-P is feasible with predictable AEs .
In summary, studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aim to conduct a prospective, randomized, open-label, multi-center clinical study to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 2,413 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HER2-positive breast cancer
Drug: Docetaxel · Drug: Carboplatin · Drug: Trastuzumab · Drug: Pertuzumab
HER2-positive breast cancer
Drug: Carboplatin · Drug: Trastuzumab · Drug: Pertuzumab · Drug: Nab paclitaxel
Luminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer
Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Docetaxel
Luminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer
Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Nab paclitaxel
Luminal breast cancer (HER2-, with 1-3 lymph nodes)
Drug: Docetaxel · Drug: Cyclophosphamide
Luminal breast cancer (HER2-, with 1-3 lymph nodes)
Drug: Nab paclitaxel · Drug: Cyclophosphamide
75 mg/m2, d1, q3w,6 cycles
AUC 6, d1, q3w,6 cycles
starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w,6 cycles
starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w ,6 cycles
220 mg/m2, d1, q3w,6 cycles
90 mg/m2, d1, q3w ,4 cycles ,followed by docetaxel
600 mg/m2, d1, q3w × 4 cycles followed by docetaxel
100 mg/m2, d1, q3w × 4 cycles
90 mg/m2,d1, q2w × 4 cycles followed by nab-paclitaxel
600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel
125 mg/m2, d1,8,15, q3w× 4 cycles
600 mg/m2, d1, q3w × 6 cycles
5-year DFS
5-year disease-free survival
Time frame: 5-years
DMFS
distant metastasis-free survival
Time frame: 2 years
OS
overall survival
Time frame: 10 years
RFS
recurrence-free survival
Time frame: 2 years
Remission rate of neurotoxicity
Time frame: 5 years
The incidence of other AEs
Time frame: 5 years
Plan to share: No
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Second Affiliated Hospital, School of Medicine, Zhejiang University