Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer

Study to Evaluate the Efficacy and Safety of Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer

The main purpose of this study was to evaluate the efficacy and safety of treatment with famitinib plus SHR6390 and endocrine therapy for hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative advanced breast cancer.

Study Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Fulvestrant; Drug: Famitinib; Drug: SHR6390

Detailed Description

This study would enroll patients with hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative advanced breast cancer, aimed to evaluate the efficacy and safety of treatment with famitinib combined with SHR6390 and endocrine therapy.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Local recurrent or metastatic breast cancer unsuitable for chemotherapy, confirmed histologically.
• HR-positive, HER2- negative breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
• Ib: Patients who received no more than 2 line of chemotherapy in advanced setting were recruited; II: Patients who had not received any chemotherapy and no more than 1 line of endocrine therapy.
• 18-75 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status 0～1.
• life expectancy is not less than 12 weeks.
• at least one measurable lesion according to RECIST 1.1.
• Absolute neutrophil count (ANC) ≥ 1.5×10^9/L, Platelets ≥90×10^9/L, Hemoglobin ≥ 90 g/L; Total bilirubin≤1.5 upper limit of normal (ULN)；Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN (ALT and AST≤5×ULN if liver metastasis); blood urea nitrogen (BUN) and Creatinine (Cr)≤1.5×ULN
• Left ventricular ejection fraction (LVEF) ≥ 50% and QTc≤470 ms

Exclusion Criteria:

• Patients who received Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine kinase inhibitors (TKI); II: Patients who received fulvestrant, everolimus or cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor;
• Ib: Patients who had symptomatic brain metastasis; II: Patients who had brain metastasis;
• Patients unsuitable for endocrine therapy;
• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
• Participated in other drug clinical trials within 4 weeks before admission
• 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.
• Active human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
• Has suffered from any heart disease
• Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
• According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
• Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever（> 38.5 ℃） of unknown origin occurs during the screening period/before the first administration.
• Researchers believe that patients are unsuitable for any other situation in this study.

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: Treatment group; Famitinib Plus SHR6390 and Endocrine therapy	Drug: Fulvestrant; Fulvestrant; Drug: Famitinib; Famitinib orally, daily or every other day; Drug: SHR6390; SHR6390 orally, daily for 3 weeks followed by 1 week off; Other Names: Dalpiciclib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RP2D in phase Ib	Recommended phase II dose (PR2D) in phase Ib	Up to 4 weeks
ORR in phase II	Objective response rate (ORR) by investigator in phase II	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR in phase Ib	ORR by investigator in phase Ib	up to 2 years
PFS in phase Ib	Progression-Free Survival (PFS) in phase Ib	up to 2 years
PFS in phase II	Progression-Free Survival in phase II	up to 2 years
AE	The number of patients experiencing any adverse events (AE) during the phase II study time	up to 2 years

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Principal Investigator: min yan, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): July 3, 2024

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Receptor Antagonists; Estrogen Antagonists; Fulvestrant
• Other Study ID Numbers: BC-IIT-FMTN-SHR6390-ET

Drug and device information, study documents

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