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mTOR Inhibitor

Palbociclib With Everolimus + Exemestane In BC

Phase 1 & 2

Waitlist Available

Led By Sara Tolaney, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease is evaluated and followed-up every 8 weeks, with median of 20.04 months and maximum of 35.64 months.

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and HER2-negative. The names of the study interventions involved in this study are: * Palbociclib * Everolimus * Exemestane

Eligible Conditions

Breast cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease is evaluated and followed-up every 8 weeks, with median of 20.04 months and maximum of 35.64 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease is evaluated and followed-up every 8 weeks, with median of 20.04 months and maximum of 35.64 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease is evaluated and followed-up every 8 weeks, with median of 20.04 months and maximum of 35.64 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Benefit Rate (CBR) [Phase 2a]

Secondary study objectives

Disease Control Rate (DCR) [Phase 2a]

Duration of Response (DOR) [Phase 2a]

Median Progression Free Survival (PFS) [Phase 2a]

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Palbociclib, Everolimus, ExemestaneExperimental Treatment3 Interventions

* Palbociclib will be administered orally, 100mg, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle) * Everolimus will be administered orally, 5mg, once daily on a 28 day schedule * Exemestane will be administered orally, 25mg, once daily on a 28 day schedule

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

FDA approved

Everolimus

FDA approved

Exemestane

FDA approved

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