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1

Increasing Dose of CDK4/6 Inhibitors with Hormone Therapy to Manage Side Effects for People with Metastatic HR+, HER2- Breast Cancer

Comparing Oral Drug Dosing Strategies in Older Patients with Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: the CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Purpose: To study increasing the dose of CDK4/6 inhibitors to help people manage side effects and continue taking CDK4/6 inhibitors as prescribed.

Who is this for?: People at least 65 years old with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to receive a CDK4/6 inhibitor with hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Regular dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Increasing low dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are in group 1, you will continue the normal dose (unless you need to decrease the dose due to challenging side effects).</li> <li class="seamTextUnorderedListItem">If you are in group 2, you will increase your dose every month (unless you have challenging side effects) up to the normal dose.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06377852' target='_blank'>ClinicalTrials.gov</a> </li></ul>
1

Increasing Dose of CDK4/6 Inhibitors with Hormone Therapy to Manage Side Effects for People with Metastatic HR+, HER2- Breast Cancer

Comparing Oral Drug Dosing Strategies in Older Patients with Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: the CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
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Nearest Location:
641 miles
Ironwood Cancer & Research Centers
Glendale, AZ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06377852

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Phase III

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