HER-2-positive Advanced Breast Cancer

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Review clinical trials related to HER-2-positive Advanced Breast Cancer. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy

1. The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer.This trial also aims to evaluate the safety profile, breast-conserving surgery rate after neoadjuvant therapy, and long-term efficacy of this combination regimen. 2. Study Interventions All enrolled patients will receive neoadjuvant combination treatment for 6 cycles (21 days per cycle) as follows: * Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, for a total of 6 cycles. * Subcutaneous pertuzumab and trastuzumab fixed-dose combination: Administered subcutaneously on Day 1 of each cycle for 6 cycles. The loading dose is 15 mL (1200 mg pertuzumab + 600 mg trastuzumab), and the maintenance dose is 10 mL (600 mg pertuzumab + 600 mg trastuzumab). After surgery, the subsequent adjuvant treatment will be determined by the investigator based on pathological response status and the latest clinical guidelines. 3. Participant Procedures (Consistent with Provided Example Structure) The main questions this study aims to answer are: * Does oral paclitaxel solution combined with subcutaneous dual HER2 blockade improve the pCR rate in patients with HER2-positive early or locally advanced breast cancer? * What are the safety profiles and tolerability of this oral chemotherapy plus subcutaneous targeted combination regimen? * Can this regimen improve breast-conserving surgery rate and provide favorable long-term survival outcomes? 4. Participants will: * Take oral paclitaxel solution and receive subcutaneous dual-target injection per study schedule for 6 neoadjuvant cycles * Complete regular on-site clinic visits, physical examinations, and laboratory tests throughout the treatment period * Undergo standardized pathological evaluation after neoadjuvant therapy and receive subsequent surgical treatment * Accept long-term follow-up for survival status and adverse event monitoring

Participants needed: 65
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: The First Affiliated Hospital with Nanjing Medical UniversityUpdated: Sep 30, 2026
Eligibility criteria

Aged ≥ 18 years. For premenopausal and perimenopausal patients, a negative pregn... [+10]

Male breast cancer or inflammatory breast cancer. [+10]

Status: Not yet recruiting

Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer

The JAZMINE study is a multicenter, open-label, non-comparative, phase Ib/II clinical trial to evaluate safety and preliminary efficacy of zanidatamab in combination with tucatinib and chemotherapy (capecitabine or eribulin mesylate) in HER2-positive advanced breast cancer.

Participants needed: 24
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: MedSIRUpdated: Apr 23, 2026
Eligibility criteria

Participants must be capable of understanding the purpose of the Study and have... [+21]

Participation in another clinical trial, interventional or observational, until... [+35]

Status: Recruiting

A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy

Purpose of the Study: Primary Study Objective: To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab Secondary Research Objectives: To evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive early or locally advanced breast cancer after trastuzumab adjuvant therapy Study Endpoints Primary Study Endpoint: Invasive disease free survival (iDFS) Secondary Study Endpoints: 1. overall survival (OS); 2. disease-free survival (DFS); 3. distant metastasis free survival (DDFS); 4. safety Study Population: Patients with early or locally advanced HER-2 positive breast cancer with clinical stage 0-III who have received prior neoadjuvant or adjuvant therapy. where the neoadjuvant and/or adjuvant treatment phase has been completed at least ≥24 weeks (8 dosing cycles) of trastuzumab therapy and the time interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year Study Design: Single-arm, multicenter, interventional study Administration Pyrrolitinib: The recommended dose of this product is 400 mg orally once daily within 30 minutes after breakfast for 52 weeks (approximately one year). Dose adjustments may be made in accordance with this protocol, taking into account adverse reactions in subjects. Each consecutive suspension of piretinib during the course of the study should not exceed 14 days, prophylactic use of medications for the treatment of diarrhea is permitted during the course of treatment, multiple suspensions of study medication due to adverse events are permitted, and doses of piretinib that are missed for any reason will not be made up.

Participants needed: 67
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: FemaleType: InterventionalSponsor: Zunyi Medical CollegeUpdated: Jun 24, 2024Locations: 1
Eligibility criteria

Age: 18-75 years; [+12]

Confirmed local/regional recurrence/metastasis at enrollment; [+5]