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Hormone Therapy

Ribociclib + Endocrine Therapy for Breast Cancer Recurrence (RaPhLRR Trial)

Phase 2

Recruiting

Led By Oana Danciu, MD

Research Sponsored by Oana Danciu

Eligibility Criteria Checklist

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

Must have

Male or female age ≥ 18 years at the time of consent

Ability to swallow and retain oral medication

Must not have

Patient has any other concurrent severe and/or uncontrolled medical condition that would cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol

Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new combination therapy of ribociclib and ET is effective and safe in treating patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Who is the study for?

This trial is for adults with hormone receptor positive, HER2-negative breast cancer that has locally recurred. They must be able to take oral medication, have good organ function and performance status, and not be pregnant or breastfeeding. Exclusions include prior CDK4/6 inhibitor treatment for recurrence, severe medical conditions, certain heart diseases, other malignancies affecting safety assessments, major surgery within 14 days before the study drug starts or GI issues affecting drug absorption.

What is being tested?

The trial tests the effectiveness and safety of ribociclib combined with a physician's choice of endocrine therapy (Letrozole, Exemestane, Fulvestrant or Anastrozole) in patients who've had local breast cancer recurrence. It's an open label phase II study where all participants receive the same treatment without a comparison group.

What are the potential side effects?

Potential side effects may include nausea, fatigue, hair loss from endocrine therapy; plus possible increased risk of infections and liver problems from ribociclib. There could also be changes in blood counts leading to bleeding or bruising risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can swallow and keep down pills.

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My breast cancer is positive for estrogen and/or progesterone receptors.

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My breast cancer is not HER2-positive.

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My breast cancer has returned in the same area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe health issues that would make it unsafe for me to join the study.

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I have Long QT syndrome or a family history of sudden death.

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I have taken CDK4/6 inhibitors for my recurring cancer.

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I do not have uncontrolled heart disease or abnormal heart rhythms.

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I don't have another cancer that could affect this treatment's safety or results.

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I haven't had major surgery in the last 2 weeks or still have major side effects from it.

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My breast cancer has spread beyond the nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recurrence Free Survival (RFS)

Secondary study objectives

Assess adverse events

Distant Metastasis-Free Survival

Overall Survival (OS)

Awards & Highlights

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: Investigational GroupExperimental Treatment5 Interventions

The drug ribociclib will be taken orally at a dose of 400 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice. All new subjects enrolled under the 08JUL2024 protocol or after will receive ribociclib 400mg daily for 21 days out of a 28-day cycle. Subjects receiving 600mg ribociclib under a prior protocol version will be switched to 400mg. Physician's choice of endocrine therapy includes: * 500 mg of fulvestrant received intramuscularly. This will be taken on Day 1 and Day 15 of Cycle 1 and on Day 1 of Cycle 2 and beyond. * 1 mg of anastrozole taken orally daily of the 28 day cycle. * 2.5 mg of letrozole taken orally daily of the 28 day cycle. * 25 mg of exemestane taken orally daily of the 28 day cycle. * Concomitant use with tamoxifen is not allowed. Premenopausal subjects must also be treated with ovarian suppression according to institutional standards or have undergone bilateral oophorectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

2002

Completed Phase 4

~3590

Exemestane

2003

Completed Phase 4

~7510