A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
Recruiting
Sponsor: Novartis Pharmaceuticals
Collaborators: Translational Research in Oncology
Information provided by (Responsible party):
Sponsor
ClinicalTrials.gov Identifier: NCT03701334
Protocol Info
| Short Description: |
Ribociclib + Endocrine Therapy In Breast Cancer |
| Long Description: |
A Phase III, Multicenter, 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 (NATALEE) |
| MGH Status: |
Open |
| Sponsor: |
Novartis |
| Disease Program: |
Breast |
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
Purpose
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
| Condition Title |
Intervention |
Phase |
| Early Breast Cancer
|
Ribociclib
Endocrine Therapy
|
Phase 3 |
| Study Type |
Interventional |
| 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) |
Primary Outcome Measures
Invasive Disease-Free Survival [Time Frame: 44 months] [Designated as safety issue: ]
Secondary Outcome Measures
Recurrence-free survival [Time Frame: 44 months] [Designated as safety issue: ]
Distant disease-free survival [Time Frame: 44 months] [Designated as safety issue: ]
Overall Survival [Time Frame: 91 months] [Designated as safety issue: ]
Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30 [Time Frame: 44 months] [Designated as safety issue: ]
Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30 [Time Frame: 44 months] [Designated as safety issue: ]
PK parameter Ctrough and other applicable parameters for ribociclib [Time Frame: 44 months] [Designated as safety issue: ]
| Estimated Enrollment: |
5000 |
| Study Start Date: |
December 2018 |
| Estimated Study Completion Date: |
May 2026 |
| Estimated Primary Completion Date: |
May 2026 |
| Arms |
Assigned Interventions |
Experimental:Ribociclib + Endocrine Therapy
ribociclib 400 mg once daily on days 1-21 of a 28 day cycle followed by 7 days off" and endocrine therapy (ET) once daily continuously
|
Drug:Ribociclib Ribociclib + ET |
Active Comparator:Endocrine Therapy
endocrine therapy (ET) only once daily continuously
|
Other:Endocrine Therapy Endocrine Therapy (ET) |
Eligibility
Ages Eligible for Study: N/A-N/A
Genders Eligible for Study: All
Accepts Healthly Volunteers: No
Inclusion Criteria:
- • 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
Exclusion Criteria:
- • 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
More Information
No publications provided
| Responsible Party: |
Sponsor
|
| ClinicalTrials.gov Identifier: |
NCT03701334 |
| Other Study ID Numbers: |
|
| Study First Received: |
|
| Last Updated: |
|
| Health Authority: |
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Keywords provided by Novartis:
early breast cancer (EBC)
HR+/HER2-
adjuvant
LEE011
ribociclib
CDK4/6 inhibitor
Additional relevant MeSH terms:
Breast Neoplasms
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
ClinicalTrials.gov processed this data on February 25, 2021