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NCT06874933

Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)

Recruiting now Phase 2 Last updated 12 August 2025
What this trial tests

Phase 2 trial testing Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart in HR+/HER2- Breast Cancer in 35 participants. Currently enrolling.

Timeline
4 May 2025
Primary endpoint
1 April 2027
1 April 2030

Quick facts

Lead sponsorFirst Affiliated Hospital of Zhejiang University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment35
Start date4 May 2025
Primary completion1 April 2027
Estimated completion1 April 2030
Sites3 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

First Affiliated Hospital of Zhejiang University

Who can join

Adults 18 to 75, female only, with HR+/HER2- Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response(PCR)and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Benmelstobart+anlotinib: an emerging therapeutic option in the targeted-immunotherapy era.
    Cheng P, Gu H, Chen Q, Zhao G, et al · · 2026 · PMID 42052493 · DOI 10.3389/fonc.2026.1748214

Verify or expand the search:

Other recruiting trials for HR+/HER2- Breast Cancer

Currently open trials in the same condition.

Other First Affiliated Hospital of Zhejiang University trials

Trials by the same sponsor.

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Data sources for this page

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