Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer

NCT07317778 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MA-BC-II-094
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. The main questions it aims to answer are: Is Adebrelimab plus chemotherapy better than T-EC chemotherapy alone in neoadjuvant setting of HR+/HER2-low early stage population? Is SHR-A1811-EC plus Adebrelimab better than T-EC chemotherapy and/or Adebrelimab plus chemotherapy Participants will: Take 8 cycles of standard chemotherapy at day1, every 3 weeks cycle(standard care), or take 8 cycles of adebrelimab plus standard chemotherapy at day 1, every 3 weeks cycle(experimental 2), or take 4 cycles of SHR-A1811 and Adebrelimab at day 1, every 3 weeks cycle, then 4 cycles of adebrelimab plus EC chemotherapy at day 1, every 3 weeks cycke(experimental 1). Visit the clinic once every 6 weeks at neoadjuvant period for tumor assessment. Take surgery after completion of 8 cycles of neoadjuvant therapy and assess the pathological response. Then, visit the clinic once every 12 weeks at first year and then every 6 months for tumor assessment.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3); HR Positive/HER2 Low Breast Cancer

Keywords

SHR-A1811; adebrelimab; Trastuzumab Rezetecan; HR+/HER2-low; early stage breast cancer

Outcome Measures

Primary Outcomes (1)

• tpCR(ypT0/Tis ypN0M0)

  total pathological complete response, define as ypT0/Tis ypN0 M0 assessed according to the AJCC staging criteria

  After surgery (within 1 month)

Secondary Outcomes (3)

• EFS

  from enrollment to completion of 3 years of follow up after surgery

• OS

  from enrollment to complete of 5 years follow up after surgery

• Adverse Events

  AEs were assessed from enrollment throughout the trial and for 30 days after discontinuation of treatment (90 days for serious AEs)

Study Arms (3)

Arm 1: SHR-A1811-EC + Adebrelimab

EXPERIMENTAL

4 cycles of SHR-A1811 follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles.

Drug: SHR-A1811; Drug: Adebrelimab (PD-L1 inhibitor); Drug: Anthracycline & Cyclophosphamide treatment scheme

Arm 2: T-EC + Adebrelimab

EXPERIMENTAL

4 cycles of taxane follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles.

Drug: Adebrelimab (PD-L1 inhibitor); Drug: Taxane Chemotherapy; Drug: Anthracycline & Cyclophosphamide treatment scheme

Arm 3: T-EC

ACTIVE COMPARATOR

4 cycles of taxane follow by 4 cycles of EC chemotherapy

Drug: Taxane Chemotherapy; Drug: Anthracycline & Cyclophosphamide treatment scheme

Interventions

SHR-A1811 DRUG

An anti-HER2 ADC injection, administered on day 1 of each cycle, with one cycle every 3 weeks. 4.8mg/kg or 5.6mg/kg IV, according to the outcomes of the safety run in process.

Also known as: Trastuzumab Rezetecan, T-DXh

Arm 1: SHR-A1811-EC + Adebrelimab

Adebrelimab (PD-L1 inhibitor) DRUG

A PD-L1 inhibitor, 1200mg IV, is administered on the 1st day of every 3 weeks cycle.

Also known as: SHR-A1316

Arm 1: SHR-A1811-EC + Adebrelimab; Arm 2: T-EC + Adebrelimab

Taxane Chemotherapy DRUG

Could be paclitaxel, docetaxel or Nab-paclitaxel, according to physician's choice.

Arm 2: T-EC + Adebrelimab; Arm 3: T-EC

Anthracycline & Cyclophosphamide treatment scheme DRUG

Anthracycline usually use epirubicin, 90-100mg/m2, combine with Cyclophosphamide 600mg/m2, both use at day 1, every 3 weeks cycle.

Arm 1: SHR-A1811-EC + Adebrelimab; Arm 2: T-EC + Adebrelimab; Arm 3: T-EC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG score: 0-1;
• Pathologically confirmed invasive breast cancer, with tumor stage T1c-T2, cN1-2 or T3-4 cN0-2;
• HR positive/HER2 low expression(defined as HER2 IHC 1+/2+, FISH negative);
• Known PD-L1 expression status, or sufficient tumor tissue for PD-L1 testing;
• Sufficient organ function
• Female patients who have not undergone menopause or sterilization, accept for abstain from sexual activity or use an effective contraceptive method during the treatment period and at least 7 months after the last administration of the study medication;
• Voluntarily participate and sign the informed consent form.

You may not qualify if:

• Inflammatory breast cancer;
• Previously received anti-tumor therapy or radiotherapy for any malignant tumor(not including cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma);
• Concurrently received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
• Within 4 weeks before enrollment, underwent major surgical procedures unrelated to breast cancer, or the patient has not fully recovered from such procedures;
• Had clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis and radiation pneumonia (except for radiological changes that do not require treatment), or was found to have such diseases during the screening period;
• Had any cardiac diseases, including: (1) Severe / unstable angina pectoris; (2) Requires drug treatment or has clinically significant arrhythmia; (3) Had a myocardial infarction within 6 months before enrollment; (4) Has symptomatic congestive heart failure with NYHA grade ≥ II; (5) Any other heart diseases judged by the researcher as not suitable for participation in this trial;
• Known to have had an allergic history to the components of the drug in this protocol; have a history of immunodeficiency, including positive HIV test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
• Had severe comorbidities or other conditions that would interfere with the planned treatment, or any other situation that the researcher considered the patient was not suitable for participation in this study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

Location

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Anthracyclines

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Yiqun Li

CONTACT

+86-010-87788120; Liyiqun_chcams@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 5, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): September 15, 2033
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

CN (1)