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

Phase 2

Recruiting

• Conditions: Breast Cancer; HER2-positive Breast Cancer; Triple Negative Breast Cancer
• Interventions: Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Herceptin

• Registration Number: NCT03907800
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-09
• Status Verified: 2022-10
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nab-paclitaxel + Carboplatin ± Herceptin	Herceptin	-
Nab-paclitaxel + Carboplatin ± Herceptin	Nab-paclitaxel	-
Nab-paclitaxel + Carboplatin ± Herceptin	Carboplatin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China