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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Metastatic; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation
• Intervention / Treatment: Drug: SC10914

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: zhang qingsheng, MD,PhD; Phone Number: 13913886090; Email: zhangqinsheng@sh-qingfeng.net
• Study Contact Backup: Name: wu han, MD; Phone Number: 13770507990

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: hu xichun, MD; Phone Number: 13811999030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SC10914 group	Drug: SC10914; SC10914 400mg tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall Survival (OS)	from eligible until death due to any cause	Assessed up to a maximum of 30 months

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: hu xichun, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: QF-SC10914-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No