Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.

Official Title
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Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer

Conditions
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Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer

Intervention / Treatment
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* Drug: Nab-paclitaxel
* Drug: Carboplatin
* Drug: Herceptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures. Age at diagnosis ≥ 18 years, female. Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells； HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0. cT2-4NanyM0 or cTanyN1-3M0 ECOG ≤ 1, LVEF ≥ 55%. Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 / L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, total bilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL Patients must be available and compliant for treatment and follow-up. Exclusion Criteria: Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy. Known or suspected congestive heart failure (> NYHA I) Currently active infection or severe symptomatic visceral disease. Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol rior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel + Carboplatin ± Herceptin<br> | Drug: Nab-paclitaxel<br>* 125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.<br>Drug: Carboplatin<br>* AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles<br>Drug: Herceptin<br>* In case of HER2-positive, patients receive Herceptin weekly during all cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response (ypT0/is ypN0) rate | Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ. | 16 weeks (at the time of definitive surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive disease-free survival (IDFS) | IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer) | 5 years | 
| Distant disease-free survival (DDFS) | DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer) | 5 years | 
| Objective response rate (ORR) | ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1 | 16 weeks (at the time of definitive surgery) | 
| Breast conservation rate | To determine the breast conservation rate after neoadjuvant treatment. | 16 weeks (at the time of definitive surgery) | 
| Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped | Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped. | during treatment (16 weeks) |