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There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.
Breast cancer is a heterogenous disease with at least 4 intrinsic subtypes including Luminal A, Luminal B, HER2 enriched, Basal-like and normal breast like. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different chemo-regimen in different subtypes. This is especially true in neoadjuvant chemotherapy setting where no standard regimen has ever been established. Therefore, we designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of breast cancer in neoadjuvant treatment. Patients were first classified into Luminal type, Her2 positive type and triple-negative type by immunohistochemistry exam of ER/PR/HER2 in core needle biopsy and then randomized to received either dose dense paclitaxel in Luminal type or dose dense paclitaxel plus carboplatin with or without trastuzumab in HER2 positive type or dose dense paclitaxel plus carboplatin in triple-negative type.The control groups in each subtype all receive paclitaxel plus epirubicin every 3 weeks. The duration of treatment is 4-6 cycles. Primary endpoint is the pathological CR rate in each subtypes. Secondary endpoints include disease free survival, objective response rate, safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luminal subtype test | Experimental | Paclitaxel 175mg/m2, every 2 weeks as a cycle for 4-6 cycles |
|
| Luminal subtype control | Active Comparator | Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles |
|
| Her2 positive subtype test | Experimental | Paclitaxel 175mg/m2 plus carboplatin AUC 4 with or without trastuzumab every 2 weeks as a cycle for 4-6 cycles |
|
| Her2 positive subtype control | Active Comparator | Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 with or without trastuzumab every 3 weeks as a cycle for 4-6 cycles |
|
| Triple negative subtype test | Experimental | Paclitaxel 175mg/m2 plus carboplatin AUC 4 every 2 weeks as a cycle for 4-6 cycles |
|
| Triple negative subypte control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel and carboplatin | Drug |
| ||
| Paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response(pCR) rate of breast and axilla after surgery | pathological complete response(pCR) of breast and axilla after surgery means after operation, no invasive component can be found in both breast and axillary lymph nodes. The pCR rate is calculated by number of patients having pCR after sugery divided by number of patients receiving neoadjuvant chemotherapy. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 3years and 5years after operation | |
| Overall survival | 3 years and 5years after operation | |
| Adverse event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Fan, MD | Contact | 861087788114 | fanyingfy@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Binghe Xu, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | 100021 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Active Comparator |
Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles |
|
| Drug |
|
| Epirubicin and Paclitaxel | Drug |
|
| during screening and treatment, withing 21 days after day 1 of last cycle |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |