A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

NCT ID: NCT05911958

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2029-05-31

Brief Summary

HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.

Detailed Description

This prospective, single-arm study is being conducted to evaluate the efficacy and safety of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive, Low HER2 Expression. Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. The follow-up visit will last for at least 5 years.

Conditions

HER2 Low Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A1811

SHR-A1811 group

Group Type: EXPERIMENTAL

SHR-A1811 for injection

Intervention Type: DRUG

SHR-A1811 for injection

Interventions

SHR-A1811 for injection

SHR-A1811 for injection

Intervention Type: DRUG

Other Intervention Names

SHR-A1811 group

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 to 70 years old (inclusive);

2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;

3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;

4. ECOG performance status of 0-1;

5. Normal organ and bone marrow function;

6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;

7. Patients voluntarily joined the study and signed informed consent;

Exclusion Criteria

1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;

2. Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;

3. Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;

4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;

5. Clinically significant pulmonary or cardiovascular disease;

6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;

7. Known to be allergic to any study drug or any of its excipients;

8. History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;

9. Pregnant and lactating women;

10. Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhenzhen Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenzhen Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenzhen Liu, Professor

Role: CONTACT

liuzhenzhen73@126.com

+86-13603862755

Jiujun Zhu, PhD

Role: CONTACT

bigapple0601@126.com

+86-13676962766

Facility Contacts

Jiao DeChuang

Role: primary

jiaodechuang1982@163.com

13598004327

Other Identifiers

BC-NEO-IIT-SHR-A1811

Identifier Type: OTHER

Identifier Source: secondary_id

HELEN-015

Identifier Type: -

Identifier Source: org_study_id