Radiation boosts standard therapy in advanced breast cancer trial
NCT ID NCT04563507
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests whether adding targeted radiation (SBRT) to standard hormone therapy and a CDK4/6 inhibitor can help women with metastatic HR+ HER2- breast cancer live longer without their disease worsening. About 102 participants will be randomly assigned to receive either standard therapy alone or standard therapy plus SBRT to each metastatic lesion. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic Body Radiation Therapy (SBRT)
- What this could lead to
- If successful, adding SBRT to standard hormone therapy and CDK4/6 inhibitors could delay cancer progression in women with metastatic breast cancer.
- What could go wrong
- This is a Phase 2 trial with only 102 participants, so results may not apply to all patients. Radiation side effects and the possibility that the combination offers no added benefit are key risks.
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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About 102 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- 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 to 90 years
- 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.
Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) (AND/OR) Previously diagnosed and treated metastatic BC, for the first time being offered CDK4/6 inhibition with endocrine therapy ( can have progressed after endocrine therapy before) Male Breast cancer patients are eligible to participate on the trial. Inclusion Criteria: * Female ≥ 18 years of age pre and post-menopausal * Metastatic disease (≤ 5 sites of measurable disease by RECIST) * Eligible for treatment with CDK4/6 + aromatase inhibitors * Premenopausal status is defined as either: * Patient had last menstrual period within the last 12 months, OR * If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR * In case of therapy-induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range. * Patients who have undergone bilateral oophorectomy are eligible. * Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Biopsy proven diagnosis of HR+HER2- metastatic breast cancer. ER expression is \>10% * Patient needs to be able to understand and demonstrate a willingness to sign a written informed consent document * Hematological WBC ≥ 2000/uL * Absolute neutrophil count (ANC) ≥1500/µL * Platelets ≥100 000/µL * Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for the participant with creatinine levels \>1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN * Coagulation International normalized ratio (INR) OR prothrombin time (PT) * Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the participant is receiving anticoagulant therapy if PT or aPTT is within the therapeutic range of intended use of anticoagulants Exclusion Criteria: * Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy * Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy * Any lesion \>5 cm in greatest diameter. * Inability to obtain histologic proof of metastatic breast cancer * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. * Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded. * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has an active infection requiring systemic therapy. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Patients with uncontrolled brain metastases
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brooklyn Methodist Hospital - NewYork Presbyterian
RECRUITINGNew York, New York, 11215, United States
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New York Presbyterian Hospital - Queens
RECRUITINGNew York, New York, 11355, United States
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Weill Cornell Medicine
RECRUITINGNew York, New York, 10065, United States
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