Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
estimated completion
Principal Investigator
by Nicholas McAndrew (ucla)Melanie Majure (ucsf)

Description

Summary

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

Official Title

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Keywords

Early Breast Cancer early breast cancer (EBC) HR+/HER2- adjuvant LEE011 ribociclib CDK4/6 inhibitor Breast Neoplasms Endocrine Therapy Ribociclib + Endocrine Therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient is ≥ 18 years-old at the time of PICF signature
  • Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.
  • Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
  • Patient has breast cancer that is positive for ER and/or PgR
  • Patient has HER2-negative breast cancer
  • Patient has available archival tumor tissue from the surgical specimen
  • Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: anatomic stage group II or III
  • If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
  • If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years

You CAN'T join if...

  • Patient has received any CDK4/6 inhibitor
  • Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization. Patient is concurrently using hormone replacement therapy.
  • Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
  • Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
  • Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
  • Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
  • Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization
  • Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
  • Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization
  • Patient has known HIV infection, Hepatitis B or C infection
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
  • Patient is currently receiving any of the following substances within 7 days before randomization - Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
  • is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment
  • Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
  • Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial.
  • Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial

Locations

  • UCLA Beverly Hills accepting new patients
    Beverly Hills California 90212 United States
  • UCLA Burbank accepting new patients
    Burbank California 91505 United States
  • UCLA Hematology Oncology accepting new patients
    Laguna Hills California 92653 United States
  • UCLA Central Regulatory accepting new patients
    Los Angeles California 90095 United States
  • UCLA Pasadena Health Care Hematology Oncology accepting new patients
    Pasadena California 941105 United States
  • UCLA Porter Ranch Hematology and Oncology accepting new patients
    Porter Ranch California 91326 United States
  • University of California San Francisco Gynecologic Oncology accepting new patients
    San Francisco California 94115 United States
  • UCLA Santa Monica Hematology / Oncology Regulatory-2 accepting new patients
    Santa Monica California 90404 United States
  • UCLA Valencia accepting new patients
    Valencia California 91355 United States
  • UCLA Cancer Center, Westlake Village accepting new patients
    Westlake Village California 91361 United States

Lead Scientists at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03701334
Phase
Phase 3
Study Type
Interventional
Last Updated