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

NCT05911958 | Recruiting Phase 2

• 2 other identifiers: HELEN-015BC-NEO-IIT-SHR-A1811
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2 Low Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Tumours (RECIST) v1.1

  Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid

  During 24 weeks of the neoadjuvant treatment

Secondary Outcomes (5)

• Incidence of Adverse Events

  from consent to 28 days after last dose

• Residual cancer burden (RCB)

  At the time of surgery

• Pathological complete response

  At the time of surgery

• Event-free survival (EFS)

  5 years

• Disease-free survival (DFS)

  5 years

Study Arms (1)

SHR-A1811

EXPERIMENTAL

SHR-A1811 group

Drug: SHR-A1811 for injection

Interventions

SHR-A1811 for injection DRUG

SHR-A1811 for injection

Also known as: SHR-A1811 group

SHR-A1811

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 70 years old (inclusive);
• Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
• HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
• ECOG performance status of 0-1;
• Normal organ and bone marrow function;
• 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;
• Patients voluntarily joined the study and signed informed consent;

You may not qualify if:

• Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
• 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;
• Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;
• Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;
• Clinically significant pulmonary or cardiovascular disease;
• Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;
• Known to be allergic to any study drug or any of its excipients;
• History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
• Pregnant and lactating women;
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Zhenzhen Liu, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu, Professor

CONTACT

+86-13603862755; liuzhenzhen73@126.com

Jiujun Zhu, PhD

CONTACT

+86-13676962766; bigapple0601@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: July 5, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): May 31, 2029
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)