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

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Disitamb Vedotin ,pyrotinib

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Li, Ph.D; Phone Number: 025-68307102; Email: real.lw@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Jiangsu Provincial People's Hospital
      • Contact: Wei Li, Ph.D; Phone Number: 025-68307102; Email: real.lw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disitamb Vedotin combined with pyrotinib; Disitamb Vedotin: 2 mg/kg，ivgtt，d1,14/28day/cycle pyrotinib:320mg, oral, every day.	Drug: Disitamb Vedotin ,pyrotinib; Disitamb Vedotin combined with pyrotinib; Other Names: Regular Visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival （DFS)	The time from randomization until disease recurrence or death due to progression of the disease.	3 years
Overall Survival（OS）	It is defined as the time from the start of treatment to death for any reason.	5year
The Number of Participants Who Experienced Adverse Events (AE)	according to the CTCAE's grading criteria	1 year
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: First Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HER2-positive; RC48
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20230722RC48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No