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Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab

Primary Purpose

HER2-positive Breast Cancer, Metastatic Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Trastuzumab plus chemotherapy

Trastuzumab in combination with pyrotinib plus chemotherapy

About this trial

This is an interventional treatment trial for HER2-positive Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged ≥18 and ≤75 years;
Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;
History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;
History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;
Previously reveived ≤2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included);
ECOG performance status of 0 to 1;
According to RECIST 1.1, at least one extracranial measurable lesion exists；
Signed informed consent.

Exclusion Criteria:

Patients with leptomeningeal metastasis or unstable brain metastasis;
History of neurological or psychiatric disorders;
Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.
Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
History of allergies to the drug components of this regimen;
History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;
Any other situations judged by investigator as not suitable for participating in this study.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Trastuzumab plus chemotherapy

Pyrotinib in combination with Trastuzumab plus chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

Objective Response Rate (ORR)

Adverse Events (AEs)

Full Information

NCT ID

NCT05346861

First Posted

April 20, 2022

Last Updated

April 20, 2022

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05346861

Brief Title

Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab

Official Title

Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, open-label, multi-center, parallel design study of the combination of pyrotinib, trastuzumab and chemotherapy versus trastuzumab and chemotherapy in HER2+ MBC patients, who have prior received trastuzumab and pyrotinib. Patients will be randomized in a 2:1 ratio to one of the following treatment arms. Arm A: pyrotinib + trastuzumab + chemotherapy, Arm B: trastuzumab + chemotherapy. Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawal of consent.

6. Conditions and Keywords

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

HER2-positive Breast Cancer, Metastatic Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab plus chemotherapy

Arm Type

Active Comparator

Arm Title

Pyrotinib in combination with Trastuzumab plus chemotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Trastuzumab plus chemotherapy

Intervention Description

Trastuzumab: 8 mg/kg loading dose followed by 6 mg/kg, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy Experimental: Pyrotinib +Trastuzumab + chemotherapy

Intervention Type

Drug

Intervention Name(s)

Trastuzumab in combination with pyrotinib plus chemotherapy

Intervention Description

Pyrotinib: 400 mg po QD, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Time Frame

approximately 8 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Time Frame

approximately 8 months

Title

Adverse Events (AEs)

Time Frame

From the first drug administration to within 28 days for the last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged ≥18 and ≤75 years; Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification; History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting; History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting; Previously reveived ≤2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included); ECOG performance status of 0 to 1; According to RECIST 1.1, at least one extracranial measurable lesion exists； Signed informed consent. Exclusion Criteria: Patients with leptomeningeal metastasis or unstable brain metastasis; History of neurological or psychiatric disorders; Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma; Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.); History of allergies to the drug components of this regimen; History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation; Any other situations judged by investigator as not suitable for participating in this study.

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Zhang, MD,PhD

Phone

+8664175590

Ext

85000

syner2000@163.com

12. IPD Sharing Statement

Learn more about this trial

Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab

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