SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases

NCT06975475 | Not Yet Recruiting Phase 2

• 1 other identifier: UH-SHR-A1811 and THPy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this project is to evaluate whether the sequence of Trastuzumab，pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in first line followed by Trastuzumab，pyrotinib and Nab-Paclitaxel in second line for HER2 positive breast cancer brain metastases.

Conditions

Breast Cancer

Keywords

breast caner; HER2 positive

Outcome Measures

Primary Outcomes (1)

• PFS2

  Progression-free survival after two lines of treatment (PFS2)

  2 years

Secondary Outcomes (4)

• overall survival(OS)

  4 years

• Intracranial CNS progression-free survival

  2 years

• Progression-free survival

  2 years

• adverse event

  2 years

Study Arms (2)

ARM A

EXPERIMENTAL

Trastuzumab，pyrotinib，Nab-Paclitaxel in first line;SHR-A1811 in second line

Drug: SHR-A1811,tratuzumab,pyrotinib,Nab-Paclitaxel

ARM B

ACTIVE COMPARATOR

SHR-A1811 in first line;Trastuzumab，pyrotinib，Nab-Paclitaxel in second line

Drug: SHR-A1811,tratuzumab,pyrotinib,Nab-Paclitaxel

Interventions

SHR-A1811,tratuzumab,pyrotinib,Nab-Paclitaxel DRUG

SHR-A1811:4.8mg/kg tratuzumab:Initial 8mg/kg followed by 6mg/kg pyrotinib:320mg Nab-Paclitaxel:100-150mg/m2

ARM A; ARM B

Eligibility Criteria

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

You may qualify if:

• Females ≥18 yrs old
• Pathologically confirmed HER2-positive advanced breast cancer;
• Newly diagnosed brain metastes,At least one measurable intracranial lesion
• Not received any systemic treatment for advanced stage
• Radiotherapy was allowed in patients with an urgent need for control of intracranial symptoms
• Adequate function of major organs
• Willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up.

You may not qualify if:

• Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture; 2.Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage; 3.Has received whole brain radiotherapy, chemotherapy, surgery within 2 weeks before first dose of study therapy; 4.Has known clinically significant lung disease, that is, moderate-to-severe lung disease which severely affects respiratory function, including but not limited to: idiopathic pulmonary fibrosis, pneumonitis. Prior ≥ grade 3 interstitial lung disease is not allowed to enrolment; 5.Has received full-dose anticoagulants or thrombolytics within 10 days before enrolment, or non-steroid anti-inflammatory drugs with platelet inhibition 6.Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 7.Participated in other drug clinical trials within 4 weeks before admission; 8.Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jing Yao

CONTACT

13971139665; jeaneyph@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share