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Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy

NCT ID: NCT06711068

Last Updated: 2024-12-02

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

8077 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 trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. 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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Taxanes combined with cyclophosphamide chemotherapy

Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), cyclophosphamide chemotherapy, combined with targeted therapy with trastuzumab, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year

No interventions assigned to this group

Taxanes chemotherapy

Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel) combined with trastuzumab and pertuzumab targeted therapy, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1\) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
* 2\) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
* 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.

Exclusion Criteria

* 1\) Lack of clinical pathological data (such as imaging data, pathological data);
* 2\) Preoperative neoadjuvant therapy;
* 3\) Patients with metastatic breast cancer or bilateral breast cancer;
* 4\) Failed to undergo curative 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

[email protected]
86+13671287670

Facility Contacts

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yuan peng

Role: primary

86+13671287670

Other Identifiers

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PKUPH2024Z165

Identifier Type: -

Identifier Source: org_study_id