Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Carboplatin

Cyclophosphamide

Epirubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Luminal breast cancer (HER2-, LN+), and triple negative breast cancer

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

Nab paclitaxel

90 mg/m2,d1, q3w × 4 cycles,followed by docetaxel

600 mg/m2, d1, q3w ,4 cycles,followed by docetaxel

90 mg/m2,d1, q2w × 4 cycles,followed by nab-paclitaxel

600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel

Yiding CHEN

Huihui CHEN

Yiding Chen

Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, 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.

Neoadjuvant chemotherapy refers to systemic chemotherapy as the first step for treating breast cancer patients before planned local treatment like surgery for those without distant metastasis. It is reported that preoperative neoadjuvant chemotherapy can facilitate breast conservation, render inoperable tumors operable and provide important prognostic information at an individual patient level based on response to therapy.

Previous studies have confirmed that the efficacy of albumin-bound paclitaxel in neoadjuvant therapy and was well tolerated when combined with sequential chemotherapy with anthracyclines .

The GBG69 study was the first to compare the efficacy and safety of nab-paclitaxel (nab-P) and solvent-based paclitaxel in the neoadjuvant treatment of breast cancer. The results showed that the pCR rate in the nab-P group was significantly higher than that in the solvent paclitaxel group (38% vs 29% p\<0.001). Long-term follow-up results showed that after 4 years, iDFS was also significantly improved in nab-P-treated patients compared with solvent paclitaxel (84.0% vs 76.3%; HR, 0.66; 95% CI, 0.51-0.86; P = 0.0023).

Another phase II study compared docetaxel and albumin paclitaxel in neoadjuvant chemotherapy for HER2-negative early-stage breast cancer. The results showed a slightly higher pCR rate in the nab-P group (docetaxel: 12%; nab-P: 17%). In the Ki67\>20% subgroup, the pCR rates were 16% (docetaxel) vs 24% (nab-P) respectively. demonstrating that albumin-bound paclitaxel (nab-P) appears to demonstrate greater efficacy in breast cancer compared to docetaxel.

However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, 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.

A Study for the Neoadjuvant Treatment of Breast Cancer

A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer

tumor response rate based on imaging assessment in the neoadjuvant therapy (preoperative) stage

defined as ypT0/is, ypN0 (defined as no invasive tumor in breast and axillary lymph nodes

defined as ypT0, ypN0 (no invasive or residual carcinoma in situ lesions in breast and axillary lymph nodes

Second Affiliated Hospital, School of Medicine, Zhejiang University

Luminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer

Luminal breast cancer (HER2-, with 1-3 lymph nodes)

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

90 mg/m2, d1, q3w ,4 cycles ,followed by docetaxel

600 mg/m2, d1, q3w × 4 cycles followed by docetaxel

90 mg/m2,d1, q2w × 4 cycles followed by nab-paclitaxel

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.

A Study for the Adjuvant Treatment of Breast Cancer

A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study for the Neoadjuvant Treatment of Breast Cancer	NCT05420454	Breast Cancer	Docetaxel Carboplatin Trastuzumab Pertuzumab Nab paclitaxel Epirubicin Cyclophosphamid... Docetaxel Epirubicin Cyclophosphamid... Nab paclitaxel	18 Years -	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Study for the Adjuvant Treatment of Breast Cancer	NCT05420467	Breast Cancer	Docetaxel Carboplatin Trastuzumab Pertuzumab Nab paclitaxel Epirubicin Cyclophosphamid... Docetaxel Epirubicin Cyclophosphamid... Nab paclitaxel Cyclophosphamid...	18 Years -	Second Affiliated Hospital, School of Medicine, Zhejiang University

Spots Global Cancer Trial Database for tcbhp

Every month we try and update this database with for tcbhp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tcbhp

Every month we try and update this database with for tcbhp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tcbhp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.