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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer
• Intervention / Treatment: Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Herceptin

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiayi Wu, Dr.; Phone Number: 602268 0086-21-64370045; Email: pinkscorpio@163.com

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital
    • Contact: Li Zhu, Prof.; Phone Number: 602178 0086-21-64370045; Email: pinkscorpio@163.com
    • Contact: Jiayi Wu, Dr.; Phone Number: 602268 0086-21-64370045; Email: zhuli8@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Li Zhu, Prof., Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Carboplatin; Paclitaxel; Trastuzumab
• Other Study ID Numbers: RJBC1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No