The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Disitamab Vedotin combined with Tislelizumab

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18 to 75 years old, male or female; Early or locally advanced breast cancer confirmed by pathology; Lymph node positive or lymph node negative, ER and PR negative, T ≥ 2 or lymph node negative, ER positive or PR positive, T ≥ 5; ECOG PS: 0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative; Exclusion Criteria: Stage IV breast cancer; Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; At the same time, other clinical trials have received anti-tumor therapy. If the researcher judges that the patient cannot benefit from the researcher, other anti-tumor therapy can be ended. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery; Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.

Sites / Locations

WuhanHURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Disitamab Vedotin combined with Tislelizumab

Arm Description

Subjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows: Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle

Outcomes

Primary Outcome Measures

Pathological complete remission (pCR) rate

Secondary Outcome Measures

Full Information

NCT ID

NCT05861635

First Posted

February 18, 2023

Last Updated

May 16, 2023

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT05861635

Brief Title

The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression

Official Title

Union Hospital Affiliated to Huazhong University of Science and Technology

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

February 1, 2025 (Anticipated)

Study Completion Date

February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression

Detailed Description

Studies have shown that vidicizumab has good efficacy and safety in advanced HER-2 low expression breast cancer. Vidicizumab combined with immunotherapy may be a new adjuvant treatment option for HER-2 low expression breast cancer patients. Therefore, we plan to carry out a clinical study to evaluate the efficacy, safety and tolerance of vidicizumab combined with tirelizumab during neoadjuvant therapy, in order to provide new treatment options for patients with breast cancer with HER-2 low expression in neoadjuvant therapy, improve their prognosis and improve their quality of life

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Neoadjuvant Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Disitamab Vedotin combined with Tislelizumab

Arm Type

Experimental

Arm Description

Subjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows: Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle

Intervention Type

Drug

Intervention Name(s)

Disitamab Vedotin combined with Tislelizumab

Intervention Description

Subjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows: Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle

Primary Outcome Measure Information:

Title

Pathological complete remission (pCR) rate

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age: 18 to 75 years old, male or female; Early or locally advanced breast cancer confirmed by pathology; Lymph node positive or lymph node negative, ER and PR negative, T ≥ 2 or lymph node negative, ER positive or PR positive, T ≥ 5; ECOG PS: 0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative; Exclusion Criteria: Stage IV breast cancer; Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; At the same time, other clinical trials have received anti-tumor therapy. If the researcher judges that the patient cannot benefit from the researcher, other anti-tumor therapy can be ended. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery; Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Yao, doctor

Phone

02785726375

Email

jeaneyph@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Yao

Organizational Affiliation

Xiehe Hospital

Official's Role

Study Director

Facility Information:

Facility Name

WuhanHU

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing Yao

Phone

02785726375

Email

jeaneyph@163.com

12. IPD Sharing Statement

Plan to Share IPD

No

Breast Cancer, Neoadjuvant Therapy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial