Triple drug combo aims to slow HR+/HER2- advanced breast cancer
NCT ID NCT05759572
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether adding apatinib, a drug that blocks blood vessel growth, to a CDK4/6 inhibitor and hormone therapy helps control HR+/HER2- advanced breast cancer. The trial enrolls women aged 18 to 75 with confirmed HR-positive, HER2-negative invasive breast cancer. Participants receive all three treatments as their first-line therapy. The main goal is to measure how long participants live without their cancer getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apatinib, a drug that blocks blood vessel growth, combined with a CDK4/6 inhibitor and hormone therapy
- What this could lead to
- If the combination works, it could offer a new first-line option that delays cancer growth for people with HR+/HER2- advanced breast cancer.
- What could go wrong
- This is a phase 2 trial with 145 participants, so it cannot prove the combination works better than standard care. Apatinib can cause high blood pressure, bleeding, and other side effects that may outweigh any benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 145 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Females ≥18 years and ≤ 75 years old; * Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER\> 10% tumor cell positive is defined as ER positive, PR\> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative); * Subtype of similarity network fusion-4 (SNF-4) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; * Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; * Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL; * Patients had received no previous chemotherapy or targeted therapy for metastatic disease \- Page 3 of 4 \[DRAFT\] - * Has adequate liver function and kidney function: serum creatinine * ECOG score ≤ 2 and life expectancy ≥ 3 months; * Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up Exclusion Criteria: * Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease * Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms); * Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); * is pregnant or breast feeding; * Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer, metastatic are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug combo outsmart breast cancer that resists current therapy?
- Can a drug cocktail cure metastatic breast cancer? a trial aims to find out
- Can a pill combo outpace chemotherapy for aggressive breast cancer?
- Real-world data may reveal true value of abemaciclib for advanced breast cancer
- PET scan could reveal which breast cancer patients will respond to targeted therapy
- New study aims to catch lymphedema early in breast cancer patients