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

NCT06001086 | Recruiting Phase 2

• 1 other identifier: 20230722RC48
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

HER2-positive; RC48

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease free survival （DFS)

  3 years

• Overall Survival（OS）

  5year

• The Number of Participants Who Experienced Adverse Events (AE)

  1 year

• Patient Report Outcome（PRO）

  3years

Study Arms (1)

Disitamb Vedotin combined with pyrotinib

EXPERIMENTAL

Disitamb Vedotin: 2 mg/kg，ivgtt，d1,14/28day/cycle pyrotinib:320mg, oral, every day.

Drug: Disitamb Vedotin ,pyrotinib

Interventions

Disitamb Vedotin ,pyrotinib DRUG

Disitamb Vedotin combined with pyrotinib

Also known as: Regular Visits

Disitamb Vedotin combined with pyrotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old (at the time of signing the informed consent form), regardless of gender.
• \. Subject type and disease characteristics. Histologically confirmed HER2 positive EBC subjects:
• evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.
• 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.
• 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.
• According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative).
• 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).
• \. When randomized, ECOG physical fitness status is 0 or 1 point.

You may not qualify if:

• Previous history of invasive breast cancer.
• Stage IV breast cancer according to AJCC staging system version 8.
• Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease.
• DCIS medical history, except for the subjects who only received Mastectomy
• 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.
• Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wei Li, Ph.D

CONTACT

025-68307102; real.lw@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)