Triple attack on tough breast cancer: combining targeted therapies may improve outcomes
NCT ID NCT05969184
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This trial is for women with advanced breast cancer that has both hormone receptors (HR-positive) and the HER2 protein (HER2-positive). It tests whether adding a CDK4/6 inhibitor called palbociclib to standard endocrine therapy and anti-HER2 antibodies (trastuzumab and pertuzumab) can help keep the cancer from growing longer. Participants have not received prior systemic treatment for advanced disease. The study measures how long people live without their cancer worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of palbociclib (a CDK4/6 inhibitor), trastuzumab and pertuzumab (anti-HER2 antibodies), and an endocrine therapy (letrozole or exemestane)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for people with HR-positive, HER2-positive advanced breast cancer, potentially delaying disease progression.
- What could go wrong
- This is a Phase 2 trial with a relatively small number of participants, so results may not be definitive. Combining multiple drugs also raises the risk of side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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94 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Jun 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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: * Sign the informed consent form and agree to comply with the requirements of the research protocol * Recurrent or metastatic breast cancer confirmed by histology or cytology that cannot be operated, and has not received systematic treatment for recurrent or metastatic breast cancer. * Estrogen receptor ER is positive (positive staining of ≥ 1% of tumor cell nucleus is positive) and HER2 is positive (immunohistochemistry is 3+, and/or 2+, and ISH is positive) * Age ≥ 18 years old. * ECOG physical status score is 0-1. * Life expectancy ≥ 3 months. * Be in a postmenopausal state. * Suffer from one of the following diseases defined in RECIST 1.1, and the target lesion is not suitable for surgical treatment; The target lesion has not received radiotherapy or relapses in the radiotherapy field: * At least one measurable lesion as the target lesion confirmed by CT or MRI * Non measurable disease with only bone metastasis (osteogenic disease, osteolytic disease or osteolytic osteogenic mixture) * Appropriate hematopoietic function, liver function and kidney function Exclusion Criteria: * Visceral crisis, severe organ dysfunction accompanied by clinical symptoms and signs, and the clinician judges that it is necessary to receive chemotherapy based treatment as soon as possible to obtain disease relief, including but not limited to the following situations: liver metastasis accompanied by a rapid increase of more than 1.5 times of bilirubin or more than 3 times of transaminase; Or pulmonary metastasis with dyspnea at rest; Carcinomatous lymphangitis; Bone marrow metastasis was accompanied by severe decrease of hematopoietic function; As well as asthma, inflammatory breast cancer, etc. * The subject has cancerous meningitis or has untreated central nervous system metastasis; Those who have received systematic and radical brain metastasis treatment (radiotherapy or surgery) in the past, and have been stable for at least 1 month as confirmed by imaging, and have stopped systemic hormone treatment (dose\>10mg/day prednisone or other effective hormones) for more than 2 weeks, and have no clinical symptoms can be included. * over 2 kind of Systematic treatment for metastatic breast cancer, including chemotherapy, endocrine therapy and biological targeting therapy, has been used previously. * Have received any treatment of CDK4 and CDK6 inhibitors (or participated in any clinical trial of CDK4 and CDK6 inhibitors that have not been exposed). * Have received radiotherapy within 28 days before enrollment. It is allowed to receive radiotherapy for relieving metastatic bone pain before enrollment, but the irradiated medullary bone shall not exceed 30% of the total amount. * Patients with uncontrolled lung disease, severe infection, active digestive tract ulcer requiring treatment, coagulation disorders, severe uncontrolled diabetes, connective tissue disease or bone marrow function depression and other diseases cannot tolerate the study drug treatment.
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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
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Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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Yaxin Liu
Beijing, None Selected, 100042, China
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