Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Oana Danciu
Study ID
NCT05467891
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HER2-negative Breast Cancer
  • Hormone Receptor-positive Breast Cancer
  • Locoregional Recurrence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    400 mg orally once daily Days 1-21 (28 day Cycle)
  • Fulvestrant — DRUG
    500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+
  • Anastrozole — DRUG
    1 mg orally once daily
  • Letrozole — DRUG
    2.5 mg orally once daily
  • Exemestane — DRUG
    25 mg orally once daily

Study Details

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.

Key Dates

Start date
Sep 13, 2022
Status verified
Apr 2026
Primary completion
Aug 15, 2028
Completion
Aug 15, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Group
    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.

Primary Outcome Measure

Recurrence Free Survival (RFS) [ Time Frame: 3 years ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Kyndall Thomas
[email protected]
Nusrat Jahan, MD (PRINCIPAL_INVESTIGATOR)
University of ArizonaPhoenixArizona85004
Letticia Gillis
[email protected]
(520) 621-2061
Sima Ehsani (PRINCIPAL_INVESTIGATOR)
Orlando Health Cancer InstituteOrlandoFlorida32806-
University of Illinois Cancer CenterChicagoIllinois60612
Erin Vidra
[email protected]
312-996-7902
Oana Danciu, MD (PRINCIPAL_INVESTIGATOR)
Parkview Research CenterFort WayneIndiana46845
Kari Schultz
[email protected]
260-266-9252
Melanie Clark, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Katie Carius
[email protected]
Sneha Phadke, DO (PRINCIPAL_INVESTIGATOR)
Tufts Medical CenterBostonMassachusetts02111
Larkin De Laria
[email protected]
Don Dizon, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health SystemAnn ArborMichigan48109
Cancer Answer Line
[email protected]
1-800-865-1125
Kathleen Kemmer, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health-WestWyomingMichigan49519-
University of Nebraska Medical CenterOmahaNebraska68198
Amulya Yellala, MBBS (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Yue Wang, MD, PhD
[email protected]
973-972-3681
Coral Omene, MD (PRINCIPAL_INVESTIGATOR)
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87102
Bernard Tawfik, MD
[email protected]
505-272-4946
Bernard Tawfik, MD (PRINCIPAL_INVESTIGATOR)
New York University Clinical Cancer CenterNew YorkNew York10016
Manju P Rajan
[email protected]
929-455-2435
Nancy Chan, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Ashley Davenport, MD (PRINCIPAL_INVESTIGATOR)
Providence Portland Medical CenterPortlandOregon97213
Staci Mellinger, RN
[email protected]
503-215-1979
Alison Conlin, MD, MPH (PRINCIPAL_INVESTIGATOR)
Penn State Cancer InstituteHersheyPennsylvania17033
Monali Vasekar, MD
[email protected]
Monali Vasekar, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Alex M Jones
[email protected]
843-792-5573
Abirami Sivapiragasam, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Health SystemCharlottesvilleVirginia22908
Olena Glushakova
[email protected]
Trish Millard, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Lindsey Gwaltney
[email protected]
Masey Ross, MD, MS (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53705
Danae Wolff
[email protected]
608-262-0803
Kari Wisinski, MD (PRINCIPAL_INVESTIGATOR)

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