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

NCT ID: NCT06711055

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

285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

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 high risk of recurrence and metastasis. 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 paltuzumab 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. To explore the efficacy and safety of adjuvant therapy of taxane chemotherapy combined with trastuzumab targeting therapy for low-risk HER2 positive and lymph node negative early breast cancer.

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 trastuzumab

Taxane with trastuzumab. Taxane drugs allow the selection of paclitaxel, liposomal paclitaxel, albumin paclitaxel, or docetaxel. Chemotherapy is administered in a single week regimen with 12 cycles or a 3-week regimen with 4 cycles, with target therapy 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 T1a-b (T ≤ 1cm), N0, HER2 positive, with high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T1c (1cm \< T ≤ 2cm), N0, and there are no high-risk factors (G1/G2, hormone receptor positive);
* 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

FEMALE

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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PKUPH2024Z164

Identifier Type: -

Identifier Source: org_study_id