A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Multicenter, Open Phase II Clinical Study to Evaluate the Efficacy and Safety of Disitamb Vedotin Combined With Pyrotinib in Previously Untreated Histologically Proven HER2 Positive Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001086
• Other study ID #: 20230722RC48
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Wei Li, Ph.D
• Phone: 025-68307102
• Email: real.lw[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer

Description:

The main goal of this clinical trial is to evaluate the efficacy of Disitamb Vedotin combined with pyrotinib in previously untreated histologically proven HER2 positive early breast cancer and evaluate the PCR DFS,OS and safety of the subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1.18 to 75 years old (at the time of signing the informed consent form), regardless of gender.

2. Subject type and disease characteristics. Histologically confirmed HER2 positive EBC subjects:

1. evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.

2. Single and multifocal tumors (greater than 1 tumor area limited to the same quadrant as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as HER2 positive.

3. Multicenter tumors (multiple tumors involving more than one breast quadrant) must sample one lesion from each affected quadrant and be confirmed as HER2 positive by the central laboratory.

4. According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative).

5. Clinical staging at visit (based on breast X-ray or breast MRI evaluation): Stage II-IIIC determined by the AJCC staging system, 8th edition. (f) Lymph node involvement is determined by fine needle aspiration or coarse needle aspiration biopsy (if applicable).

3. When randomized, ECOG physical fitness status is 0 or 1 point.

Exclusion Criteria:

1. Previous history of invasive breast cancer.

2. Stage IV breast cancer according to AJCC staging system version 8.

3. Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease.

4. DCIS medical history, except for the subjects who only received Mastectomy

5. According to the judgment of the researchers, there is evidence of any diseases (such as severe or uncontrolled systemic diseases, including persistent or active infections, uncontrolled hypertension, kidney transplantation and active bleeding diseases, and severe chronic gastrointestinal diseases related to diarrhea) that the researchers consider to be unfavorable for the participants to participate in the study or may affect adherence to the protocol.

6. Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Disitamb Vedotin ,pyrotinib
Disitamb Vedotin combined with pyrotinib

Locations

Country	Name	City	State
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	First Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response(pCR)	The pCR rate is defined as the proportion of subjects who, after completion of neoadjuvant therapy, showed no evidence of residual invasive lesions in H&E staining in completely excised breast specimens and all sampled local lymph nodes (ypT0/TisypN0) through central evaluation	1 year
Secondary	Disease free survival (DFS)	The time from randomization until disease recurrence or death due to progression of the disease.	3 years
Secondary	Overall Survival(OS)	It is defined as the time from the start of treatment to death for any reason.	5year
Secondary	The Number of Participants Who Experienced Adverse Events (AE)	according to the CTCAE's grading criteria	1 year
Secondary	Patient Report Outcome(PRO)	The report is directly obtained from the patient's self-report of their health status, functional status, and treatment experienceThe European O-rganization for Reasearch and Treatment of Cancer(QLQ-C30)?QLQ-BR32,EQ-5D-5L,PRO-CTCAE	3years