Clinical trial · Interventional
A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
A Phase I Study to Evaluate Safety 、Tolerability 、 Pharmacokinetics and Efficacy of SHR6390 in Combination With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
NCT05103826CI-TRIAL-00068806terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor R \& D Strategy Adjustment
Summary
Brief summary (as posted)
The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ER+ / HER2- Advanced Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR6390、Famitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR6390+famitinib
- description
- Participants will receive SHR6390 in combination with famitinib.
- interventionNames
- Drug: SHR6390、Famitinib
Primary outcomes (2)
- measure
- (Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
- timeFrame
- up to 28 days
- measure
- (Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
- timeFrame
- up to 28 days
Secondary outcomes (11)
- measure
- AEs+SAEs
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female subjects aged 18 to 75 years old; 2. ECOG performance status 0-1; 3. Life expectancy is not less than 12 weeks; 4. Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer; 5. Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1; 6. Adequate function of major organs; 7. Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up. Exclusion Criteria: 1. Confirmed diagnosis of HER2 positive disease; 2. Participants who previously received SHR6390 or VEGFR inhibitors; 3. Allergy to study drug or its components; 4. Participated in other drug clinical trials within 4 weeks before the first dose; 5. Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix; 6. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention; 7. Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment; 8. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein \>1.0g; 9. Active HBV/HCV/HIV infection; 10. The investigators determined that other conditions were inappropriate for participation in this clinical trial; 11. Pregnant or breast-feeding women; 12. Central nervous system (CNS) invasion.
References
Publications (0)
Data not yet available
No reference posted for this study.