A Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients

A Phase 2, Open-Label, Multi-Center Study of SC10914 in Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer, Who Have Received More Than 2 Prior Chemotherapy Regimens for Metastatic Disease

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04556292

Enrollment

Registered

2020-09-21

Start date

2020-08-12

Completion date

2022-08-30

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Breast Cancer Metastatic

Brief summary

This open label, multi-centre phase II study will assess the efficacy and safety of single agent SC10914 in metastatic breast cancer patients with gBRCA 1/2 mutations.

Interventions

DRUGSC10914

SC10914 400mg tid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Germline mutation in BRCA1 or BRCA2 2. Histologically or cytologically confirmed breast cancer with evidence of metastatic disease. 3. Prior therapy with an anthracycline and/or a taxane in either an adjuvant or metastatic setting 4. Patients who have received platinum (cisplatin or carboplatin, either as monotherapy or in combination) for advanced breast cancer are eligible to enter the study provided platinum-free interval at least 6 months (time from last dose of platinum chemotherapy to disease progression 5. Patients who have received platinum as potentially curative treatment for a prior cancer (e.g. ovarian cancer) or as adjuvant/neoadjuvant treatment for breast cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and eligible . 6. Patients with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy . 7. At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1. 8. ECOG performance status 0-1. 9. Adequate bone marrow, kidney and liver function

Exclusion criteria

1. Prior treatment with PARP inhibitor. 2. Patients with HER2 positive disease 3. Untreated and/or uncontrolled brain metastases 4. Known HIV (Human Immunodeficiency Virus) infection. 5. Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia 6. Pregnant or breast feeding women

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate (ORR)	Assessed up to a maximum of 30 months	Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Secondary

Measure	Time frame	Description
Progression-free Survival (PFS)	Assessed up to a maximum of 30 months	Using Independent Central Review According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Overall Survival (OS)	Assessed up to a maximum of 30 months	from eligible until death due to any cause

Countries

China

Contacts

Primary Contactzhang qingsheng, MD,PhD

zhangqinsheng@sh-qingfeng.net13913886090

Backup Contactwu han, MD

13770507990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026