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New treatment option for Breast Cancer
Official title Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT06207734
What this study is testing
What is Continuation of CDK4/6 inhibitor Palbociclib?
Continuation of CDK4/6 inhibitor Palbociclib is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Study treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a low-intervention, randomized, non-comparative, open-label, multicenter, prospective, phase II trial investigating discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer with durable disease control.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female patient has given written informed consent
- Patient is ≥ 18 years of age at time of signing the written informed consent
- Patient has been diagnosed with histologically confirmed metastatic adenocarcinoma of the breast
- Patient has documented histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative (HER2-) disease
- Patient has no curative treatment option by surgery or radiotherapy
You likely can't join if
- Patient has active (or history of) brain or leptomeningeal metastases
- Patient is pre- or perimenopausal. Patient is pregnant or breast feeding or planning to become pregnant within five times the half-life of the IMPs...
- Patient has significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction or...
- Patient has other concomitant or previous malignancy, except adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell...
- Patient has contraindication or shows hypersensitivity to the existing treatment with CDK4/6 inhibitor plus endocrine therapy
- Patient shows evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving...
See the full eligibility criteria
- Female patient has given written informed consent
- Patient is ≥ 18 years of age at time of signing the written informed consent
- Patient has been diagnosed with histologically confirmed metastatic adenocarcinoma of the breast
- Patient has documented histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative (HER2-) disease
- Patient has no curative treatment option by surgery or radiotherapy
- Patient was treated with CDK4/6 inhibitor plus endocrine therapy for at least 12 months with disease control (complete remission, partial remission or stable disease) as judged by the treating physician before planned...
- Patient has a preserved performance status (ECOG ≤ 2)
- Patient has adequate bone marrow, renal and hepatic function:
- Hemoglobin \> 9.0 g/dL
- Absolute neutrophil count judged as appropriate for study therapy by the investigator
- Platelets ≥ 100 x 109/L
- Calculated creatinine clearance judged as appropriate for study therapy by the investigator
- AST (SGOT) / ALT (SGPT) and alkaline phosphatase ≤ 2.5x ULN
- Serum albumin \> 30 g/L
- Patients considered postmenopausal according to one of the following definition:
- Women \<50 years of age who are amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and whose levels of luteinizing hormone and follicle-stimulating hormone are in the post-menopausal...
- Women ≥50 years of age who are amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago or had chemotherapy-induced...
- Artificially induced postmenopausal women (by Gonadotropin-releasing hormone [GnRH] analogs)
- WOCBP must have a negative serum pregnancy test within 7 days prior to start of trial
- Patient has active (or history of) brain or leptomeningeal metastases
- Patient is pre- or perimenopausal. Patient is pregnant or breast feeding or planning to become pregnant within five times the half-life of the IMPs after the end of treatment.
- Patient has significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction or cerebrovascular accident within 6 months prior to initiation of study...
- Patient has other concomitant or previous malignancy, except adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, cancer in complete remission for \> 5 years
- Patient has contraindication or shows hypersensitivity to the existing treatment with CDK4/6 inhibitor plus endocrine therapy
- Patient shows evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of...
- Patient participated in another clinical study with an investigational medicinal product during the last 28 days before treatment initiation or 7 half-lives of previously used trial medication, whichever is longer or...
- Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Bremen, Germany
- Dortmund, Germany
- Friedrichshafen, Germany
- Gerlingen, Germany
- Gütersloh, Germany
- Hamburg, Germany
- Mainz, Germany
- Mülheim, Germany
- Ravensburg, Germany
- Regensburg, Germany
- Singen, Germany
- Soest, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Bremen, Germany; Dortmund, Germany; Friedrichshafen, Germany; Gerlingen, Germany; Gütersloh, Germany and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.