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

Breast Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04556292
• Other study ID #: QF-SC10914-203
• Status: Recruiting
• Phase: Phase 2
• Start date: August 12, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2020
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: zhang qingsheng, MD,PhD
• Phone: 13913886090
• Email: zhangqinsheng[@]sh-qingfeng.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: August 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BRCA 1 Gene Mutation
• BRCA 2 Gene Mutation
• Breast Cancer Metastatic
• Breast Neoplasms

Intervention

Drug:
• SC10914
SC10914 400mg tid

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

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