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Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

NCT ID: NCT06722612

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2916 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2031-12-31

Brief Summary

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Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.

Detailed Description

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Conditions

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HER2-positive Breast Cancer

Keywords

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Taxane target therapy carboplatin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Taxanes combined with carboplatin

Paclitaxel drugs (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), carboplatin chemotherapy, combined with targeted therapy with trastuzumab, for a total of 6 cycles, followed by targeted therapy with trastuzumab for 1 year.

No interventions assigned to this group

Taxanes

Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), combined with targeted therapy with trastuzumab and pertuzumab, for a total of 6 cycles, followed by targeted therapy with trastuzumab and pertuzumab for 1 year.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1\) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
* 2\) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative);
* 3\) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria

* 1\) Lack of clinical and pathological data (such as imaging data and pathological data);
* 2\) Preoperative neoadjuvant therapy;
* 3\) Patients with metastatic breast cancer or bilateral breast cancer;
* 4\) Failure to perform radical surgery.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shu Wang

OTHER

Sponsor Role lead

Responsible Party

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Shu Wang

director of breast center

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yuan peng, doctor

Role: CONTACT

Phone: 86+13671287670

Email: [email protected]

Facility Contacts

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yuan peng, doctor

Role: primary

Other Identifiers

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PKUPH2024Z166

Identifier Type: -

Identifier Source: org_study_id