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

Primary Purpose

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

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel

Carboplatin

Herceptin

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nab-paclitaxel + Carboplatin ± Herceptin

Arm Description

Outcomes

Primary Outcome Measures

Pathological complete response (ypT0/is ypN0) rate

Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.

Secondary Outcome Measures

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)

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)

Objective response rate (ORR)

ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1

Breast conservation rate

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

Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.

Full Information

NCT ID

NCT03907800

First Posted

April 5, 2019

Last Updated

October 26, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03907800

Brief Title

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

Acronym

NeoPATH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nab-paclitaxel + Carboplatin ± Herceptin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel

Intervention Description

125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles

Intervention Type

Drug

Intervention Name(s)

Herceptin

Intervention Description

In case of HER2-positive, patients receive Herceptin weekly during all cycles.

Primary Outcome Measure Information:

Title

Pathological complete response (ypT0/is ypN0) rate

Description

Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.

Time Frame

16 weeks (at the time of definitive surgery)

Secondary Outcome Measure Information:

Title

Invasive disease-free survival (IDFS)

Description

Time Frame

5 years

Title

Distant disease-free survival (DDFS)

Description

DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer)

Time Frame

5 years

Title

Objective response rate (ORR)

Description

ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1

Time Frame

16 weeks (at the time of definitive surgery)

Title

Breast conservation rate

Description

To determine the breast conservation rate after neoadjuvant treatment.

Time Frame

16 weeks (at the time of definitive surgery)

Title

Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped

Description

Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.

Time Frame

during treatment (16 weeks)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiayi Wu, Dr.

Phone

0086-21-64370045

Ext

602268

pinkscorpio@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Zhu, Prof.

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Zhu, Prof.

Phone

0086-21-64370045

Ext

602178

pinkscorpio@163.com

First Name & Middle Initial & Last Name & Degree

Jiayi Wu, Dr.

Phone

0086-21-64370045

Ext

602268

zhuli8@yeah.net

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share IPD

Learn more about this trial

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

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