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

NCT04556292 | Unknown Phase 2 DMC

• 1 other identifier: QF-SC10914-203
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free Survival (PFS)

  Assessed up to a maximum of 30 months

• Overall Survival (OS)

  Assessed up to a maximum of 30 months

Study Arms (1)

SC10914 group

EXPERIMENTAL

Drug: SC10914

Interventions

SC10914 DRUG

SC10914 400mg tid

SC10914 group

Eligibility Criteria

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

You may qualify if:

• Germline mutation in BRCA1 or BRCA2
• Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
• Prior therapy with an anthracycline and/or a taxane in either an adjuvant or metastatic setting
• 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
• 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 .
• 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 .
• 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.
• ECOG performance status 0-1.
• Adequate bone marrow, kidney and liver function

You may not qualify if:

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

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• hu xichun, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhang qingsheng, MD,PhD

CONTACT

13913886090; zhangqinsheng@sh-qingfeng.net

wu han, MD

CONTACT

13770507990

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: August 12, 2020
• Primary Completion: March 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)