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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer; HER2-positive Breast Cancer; Triple Negative Breast Cancer

Treatments: Drug: Nab-paclitaxel; Drug: Herceptin; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03907800

RJBC1801

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
2. Age at diagnosis ≥ 18 years, female.
3. 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.
4. cT2-4NanyM0 or cTanyN1-3M0
5. ECOG ≤ 1, LVEF ≥ 55%.
6. 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
7. Patients must be available and compliant for treatment and follow-up.

Exclusion criteria

1. Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
2. Known or suspected congestive heart failure (> NYHA I)
3. Currently active infection or severe symptomatic visceral disease.
4. Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
5. rior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
6. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
7. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Nab-paclitaxel + Carboplatin ± Herceptin

Experimental group

Treatment:

Drug: Carboplatin

Drug: Herceptin

Drug: Nab-paclitaxel