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Metastatic Breast CancerPhase 1/2NCT05176080

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

A Phase 1/2 study testing Famitinib, SHR6390 and Fulvestrant in people with Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Famitinib, SHR6390 and Fulvestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
8 Dec 2021to 3 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Famitinib, SHR6390, Fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FamitinibDrug

    Famitinib orally, daily or every other day

  • SHR6390Drug

    Also called Dalpiciclib

    SHR6390 orally, daily for 3 weeks followed by 1 week off

  • FulvestrantDrug

    Fulvestrant

Study groups in NCT05176080
Study groupRoleWhat they receive
Treatment groupExperimentalFamitinib Plus SHR6390 and Endocrine therapy
Receives: Drug: Famitinib; Drug: SHR6390; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D in phase Ib

    Recommended phase II dose (PR2D) in phase Ib

    Measured: Up to 4 weeks

  2. ORR in phase II

    Objective response rate (ORR) by investigator in phase II

    Measured: up to 2 years

Secondary outcomes (4)

  1. ORR in phase Ib

    ORR by investigator in phase Ib

    Measured: up to 2 years

  2. PFS in phase Ib

    Progression-Free Survival (PFS) in phase Ib

    Measured: up to 2 years

  3. PFS in phase II

    Progression-Free Survival in phase II

    Measured: up to 2 years

  4. AE

    The number of patients experiencing any adverse events (AE) during the phase II study time

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start8 Dec 2021
  3. Primary completion3 Jul 2024
  4. Study completion3 Jul 2024

Why it stopped: Investigators' decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05176080
Sponsor's protocol ID
BC-IIT-FMTN-SHR6390-ET
Status last verified
Oct 2024
First submitted
18 Nov 2021
Last updated
17 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang M, Niu L, Lyu H, Liu Z, Zeng H, Lu Z, Chen X, Qiao J, Yuan P, Zhao S, Sun H, Wang J, Feng Y, Yan M. Addition of angiogenesis inhibitors to CDK4/6 inhibitors and fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer. Chin Med J (Engl). 2026 Jul 7. doi: 10.1097/CM9.0000000000004191. Online ahead of print.

    PubMed 42421507

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Famitinib, SHR6390 and Fulvestrant in people with Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Investigators' decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D in phase Ib (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05176080, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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