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

Primary Purpose

HER2 Low Breast Carcinoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-A1811 for injection
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2 Low Breast Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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; Exclusion Criteria: 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.

Sites / Locations

  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-A1811

Arm Description

SHR-A1811 group

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Tumours (RECIST) v1.1
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid

Secondary Outcome Measures

Incidence of Adverse Events
Evaluate the nature, incidence and severity of SHR-A1811 adverse events according to CTCAE 5.0
Residual cancer burden (RCB)
Residual cancer burden (RCB)
Pathological complete response
pCR: ypT0/is ypN0
Event-free survival (EFS)
EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause
Disease-free survival (DFS)
Disease-free Survival, From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause

Full Information

First Posted
June 12, 2023
Last Updated
September 26, 2023
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05911958
Brief Title
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Official Title
Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Low Breast Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-A1811
Arm Type
Experimental
Arm Description
SHR-A1811 group
Intervention Type
Drug
Intervention Name(s)
SHR-A1811 for injection
Other Intervention Name(s)
SHR-A1811 group
Intervention Description
SHR-A1811 for injection
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Tumours (RECIST) v1.1
Description
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid
Time Frame
During 24 weeks of the neoadjuvant treatment
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Evaluate the nature, incidence and severity of SHR-A1811 adverse events according to CTCAE 5.0
Time Frame
from consent to 28 days after last dose
Title
Residual cancer burden (RCB)
Description
Residual cancer burden (RCB)
Time Frame
At the time of surgery
Title
Pathological complete response
Description
pCR: ypT0/is ypN0
Time Frame
At the time of surgery
Title
Event-free survival (EFS)
Description
EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause
Time Frame
5 years
Title
Disease-free survival (DFS)
Description
Disease-free Survival, From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenzhen Liu, PhD
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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