NCT06693037

Recruiting

Adjuvant Therapy Choice for Non-pCR HER2 Positive Early Brea...

Shu Wang Source

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Other study identifiers

Sponsor study identifier

PKUPH2024Z169

Study Type

observational

Estimated enrollment

2,092

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2019

Actual (reported)

Primary Completion

December 31, 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

Chemotherapy combined with trastuzumab and patuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. The survival rate of patients with pathological complete response (PCR) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-PCR. Therefore, studies have confirmed that adjuvant therapy for patients with non-PCR after neoadjuvant chemotherapy can further improve the prognosis and survival of this population. However, the results of previous studies are based on trastuzumab target therapy in neoadjuvant therapy. Therefore, there are different recommendations for the current guidelines of adjuvant therapy after trastuzumab combined pertuzumab target neoadjuvant therapy. Patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology. The effect of postoperative adjuvant therapy with trastuzumab and patuzumab or replacement of T-DM1 on survival.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 2,092 participants
Study completion date: December 31, 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2019
Actual (reported)
First Submitted
November 14, 2024
Actual (reported)
First Posted
November 18, 2024
Actual (reported)
Primary Completion
December 31, 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: November 20, 2024
Status Verified: November 2024
Last Update Submitted: November 17, 2024

Conditions

HER2-positive Breast Cancer

Keywords

neoadjuvant chemotherapynon-pCRT-DM1

Outcome Measures

Primary Outcomes (1)

invasive disease free survival
Time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause
3 years

Secondary Outcomes (4)

disease free survival
3 years
distant disease free survival
3 years
breast cancer specific survival
3 years
overall survival
3 years

Study Arms (2)

Trastuzumab combined with pertuzumab

The postoperative adjuvant regimen was trastuzumab combined with pertuzumab, and the planned treatment duration was 1 year

T-DM1

The postoperative adjuvant regimen was T-DM1, and the planned treatment duration was 1 year

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

HER2 positive breast cancer patients with residual invasive breast cancer after neoadjuvant chemotherapy combined with trastuzumab and pertuzumab

You may qualify if:

\) Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;

Sponsors & Collaborators

Shu Wang
Otherlead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

yuan peng, DrCONTACT

Biospecimen

Retention: SAMPLES WITH DNA

Tumor paraffin sample for each patient

Study Officials

shu wang, doctor
Peking University People's Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan peng, doctor

CONTACT

86+13671287670 13671287670@163.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Target Duration: 3 Years
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: director of breast center

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 18, 2024

Study Start

January 1, 2019

Actual (reported)

Primary Completion

December 31, 2031

Estimated

NCT03588091

Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer

Phase 3Completed

NCT06700369

De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients

Recruiting

NCT06711055

Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer

Recruiting

NCT04094896

TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer

Phase 2Unknown

NCT04481932

Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer

Phase 2Recruiting

NCT04281641

Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer

Not ApplicableRecruiting

\) The clinical stages before treatment were T1-T4, N0-N3, M0;

\) Received treatment and operation in our hospital, and had hospitalization records;

\) Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy

\) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes;

\) Has signed and agreed to participate in the PKUPH breast disease cohort study.

You may not qualify if:

\) Lack of clinical and pathological data (such as imaging data and pathological data);
\) Patients with metastatic breast cancer or bilateral breast cancer;
\) Failure to perform radical surgery;
\) Receiving other regimens besides the established neoadjuvant regimens.

Contact the study team to confirm eligibility.

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

November 20, 2024

Record last verified: 2024-11

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT06693037
Data provider: ClinicalTrials.gov
Source updated: 2024-11-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:43 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Trastuzumab combined with pertuzumab

T-DM1

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations