200 Participants Needed

Ribociclib + Endocrine Therapy for Breast Cancer Recurrence

(RaPhLRR Trial)

Recruiting at 16 trial locations
KW
MP
RM
Oana Danciu profile photo
Overseen ByOana Danciu
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Oana Danciu
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Will I have to stop taking my current medications?

If you are taking tamoxifen or toremifene, you will need to stop and have a washout period (time without taking these medications) of 35 days before starting the trial. Additionally, you cannot take certain medications, herbal supplements, or fruits that affect liver enzymes (CYP3A4/5) starting 7 days before the trial. Other medications may need to be reviewed by the study team.

Is Ribociclib plus Endocrine Therapy safe for humans?

Ribociclib, when combined with letrozole, has been shown to have a manageable safety profile in treating advanced breast cancer. Common side effects include low white blood cell counts, nausea, tiredness, diarrhea, hair loss, vomiting, constipation, headache, and back pain.12345

What makes the drug Ribociclib combined with endocrine therapy unique for breast cancer treatment?

Ribociclib, when combined with endocrine therapy like letrozole or fulvestrant, is unique because it significantly improves progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer compared to endocrine therapy alone. This combination is particularly effective for both premenopausal and postmenopausal women, offering a novel approach by targeting specific proteins (CDK 4/6) that help cancer cells grow.36789

What data supports the effectiveness of the drug Ribociclib combined with endocrine therapy for breast cancer recurrence?

Research shows that combining Ribociclib with letrozole significantly improves progression-free survival (the time during and after treatment that a patient lives with the disease without it getting worse) in patients with hormone receptor-positive, HER2-negative advanced breast cancer compared to letrozole alone.23679

Who Is on the Research Team?

Oana C. Danciu, Hematology & Oncology ...

Oana Danciu

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I finished my last cancer treatment less than 6 months ago.
I can safely receive hormone therapy as part of my treatment plan.
I have received proper treatment for a local breast cancer recurrence.
See 8 more

Exclusion Criteria

I do not have any severe health issues that would make it unsafe for me to join the study.
Treatment with any investigational drug within 30 days prior to registration or participation in any other type of medical research judged not to be scientifically or medically compatible with this study
I have Long QT syndrome or a family history of sudden death.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ribociclib and endocrine therapy of physician's choice. Ribociclib is administered at 400 mg daily for 21 days out of a 28-day cycle, and ET is administered as per physician's choice.

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of recurrence-free survival and overall survival.

3 years

Extension

Participants may continue endocrine therapy for up to 60 months as per physician's choice.

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Anastrozole
  • Exemestane
  • Fulvestrant
  • Letrozole
  • Ribociclib
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Investigational GroupExperimental Treatment5 Interventions

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Arimidex for:
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Approved in United States as Arimidex for:
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Approved in Canada as Arimidex for:
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Approved in Japan as Arimidex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oana Danciu

Lead Sponsor

Trials
1
Recruited
200+

Novartis Pharmaceuticals

Industry Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

In the MONALEESA-2 study involving 213 US patients with hormone receptor-positive, HER2-negative advanced breast cancer, ribociclib combined with letrozole significantly improved progression-free survival (PFS) to 27.6 months compared to 15.0 months with letrozole alone, indicating its efficacy as a first-line treatment.
The most common side effects of ribociclib included neutropenia (72%), nausea (69%), and fatigue (60%), highlighting the importance of monitoring for these adverse events during treatment.
Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study.Yardley, DA., Hart, L., Favret, A., et al.[2020]
In a study of 600 patients with hormone receptor-positive, HER2-negative metastatic breast cancer, both ribociclib and palbociclib combined with letrozole showed similar benefits in progression-free survival and overall survival.
The findings suggest that while both treatments are effective, the choice between ribociclib and palbociclib may depend on individual factors like endocrine sensitivity.
Treatment efficacy of ribociclib or palbociclib plus letrozole in hormone receptor-positive/HER2-negative metastatic breast cancer.Kahraman, S., Erul, E., Seyyar, M., et al.[2023]
In the MONALEESA-7 trial involving 672 premenopausal women with advanced HR-positive breast cancer, ribociclib combined with endocrine therapy significantly improved progression-free survival (23.8 months) compared to placebo (13.0 months), indicating its efficacy as a first-line treatment option.
The safety profile of ribociclib was manageable, with common grade 3 or 4 adverse events like neutropenia occurring in 61% of patients, but no treatment-related deaths were reported, suggesting that while there are risks, the benefits may outweigh them for patients.
Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial.Tripathy, D., Im, SA., Colleoni, M., et al.[2022]

Citations

Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study. [2020]
Treatment efficacy of ribociclib or palbociclib plus letrozole in hormone receptor-positive/HER2-negative metastatic breast cancer. [2023]
Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. [2022]
Ribociclib in the Treatment of Hormone-Receptor Positive/HER2-Negative Advanced and Early Breast Cancer: Overview of Clinical Data and Patients Selection. [2022]
Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. [2022]
FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. [2019]
Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. [2022]
First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. [2019]
Complete Clinical Response in Locally Advanced Metastatic de novo Breast Cancer after Front-Line Treatment with Ribociclib/Letrozole within the RIBANNA Study. [2022]
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