Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 March 2020 |
Main ID: |
EUCTR2014-001931-36-BE |
Date of registration:
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28/10/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of Efficacy and Safety of LEE011 in Premenopausal Women With Advanced Breast Cancer
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Scientific title:
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A Phase III randomized, double-blind, placebo-controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer - Monaleesa-7 |
Date of first enrolment:
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21/01/2015 |
Target sample size:
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660 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001931-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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China
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Colombia
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Greece
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Hong Kong
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Hungary
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India
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Israel
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Italy
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Japan
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Jordan
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Korea, Republic of
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Lebanon
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Mexico
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Norway
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Poland
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Portugal
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Russian Federation
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Saudi Arabia
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Singapore
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Thailand
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Turkey
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United Arab Emirates
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Information desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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41613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Name:
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Clinical Trial Information desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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41613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patient is an adult, female = 18 years old and < 60 years old at the
time of informed consent and has signed informed consent before any
trial related activities are conducted and according to local guidelines.
2. Confirmed negative serum pregnancy test (ß-hCG) before starting
study treatment or patient has had a hysterectomy.
3. Patient is premenopausal or perimenopausal at the time of study
entry.
4. Patient has advanced (locoregionally recurrent or metastatic) breast
cancer not amenable to curative therapy (e.g. surgery and/or
radiotherapy).
5. Patients who received (neo) adjuvant therapy for breast cancer are
eligible:
• If the patient has never received any prior endocrine therapy OR if =
12 months have elapsed since the patient's last dose of adjuvant
therapy, then the patient is eligible to receive tamoxifen + goserelin OR
a NSAI + goserelin for advanced breast cancer based on the
investigator's choice.
• if tamoxifen or fulvestrant was the last prior (neo) adjuvant therapy
and the last dose was given < 12 months prior to randomization, then
the patient is eligible to receive a NSAI (letrozole or anastrazole) +
goserelin for advanced breast cancer.
• If letrozole, anastrozole, or exemestane was the last prior (neo)
adjuvant therapy and the last dose was given < 12 months prior to
randomization, then the patient is eligible to receive tamoxifen +
goserelin for advanced breast cancer.
6. Patients who received = 14 days of tamoxifen or a NSAI (letrozole or
anastrozole) with or without goserelin or goserelin <= 28 days for
advanced breast cancer prior to randomization are eligible. Patients
must continue treatment with the same hormonal agent + goserelin
during the study. No treatment interruption is required for these
patients prior to randomization.
Note: Patients receiving goserelin for reasons other than for advanced
breast cancer treatment are eligible (e.g. endometriosis). Patients who
received <= 28 days goserelin for advanced breast cancer are eligible.
7. Patients who have received up to 1 line of chemotherapy for advanced
breast cancer and have been discontinued 28 days before randomization
are eligible.
Note: if a cytotoxic chemotherapy regimen was discontinued for reasons
other than disease progression and lasted less than 21 d, this regimen
does not count as a prior line of chemotherapy.
8. Patient has a histologically and/or cytologically confirmed diagnosis
of estrogen-receptor positive and/or progesterone receptor positive
breast cancer by local laboratory (based on most recently analyzed
biopsy).
9. Patient has HER2-negative breast cancer (based on most recently
analyzed biopsy) defined as a negative in situ hybridization test or an
Exclusion criteria: 1. Patient who has received a prior CDK4/6 inhibitor.
2. Patient has a known hypersensitivity to any of the excipients of
LEE011 or goserelin or hormonal treatment assigned (tamoxifen, NSAI
(letrozole or anastrozole)).
3. Patient is postmenopausal.
4. Patients who currently have inflammatory breast cancer on screening.
5. Patient who received any prior hormonal anti-cancer therapy for
advanced breast cancer, except for = 14 days of tamoxifen or NSAI or
goserelin >= days for advanced breast cancer prior to randomization.
6. Patient who has not had resolution of all acute toxic effects of prior
anti-cancer therapy to NCI CTCAE version 4.03 Grade =1 (except
alopecia or other toxicities not considered a safety risk for the patient at
investigator's discretion).
7. Patient has a concurrent malignancy or malignancy within 3 years of
randomization, with the exception of adequately treated basal cell skin
carcinoma, squamous cell skin carcinoma, non-melanomatous skin
cancer or curatively resected cervical cancer.
8. Patient with CNS metastases.
Note: CNS involvement must be ruled out by assessments if a patient has
any signs or symptoms indicating potential CNS metastases
9. Patient has impairment of gastrointestinal (GI) function or GI disease
that may significantly alter the absorption of the study drugs (e.g.,
ulcerative diseases, uncontrolled nausea, vomiting, diarrhea,
malabsorption syndrome, or small bowel resection)
10. Patient has a known history of HIV infection (testing not mandatory)
11. Patient has any other concurrent severe and/or uncontrolled medical
condition that would, in the investigator's judgment, contraindicate
patient participation in the clinical study (e.g., chronic pancreatitis,
chronic active hepatitis, etc.)
12. Clinically significant, uncontrolled hearth disease and/or
cardiac repolarization abnormality.
13. Patient is currently receiving any of the substances described in the
protocol and cannot be discontinued 7 days prior to the start of the
treatment.
14. Patient has had major surgery within 14 days prior to starting study
drug or has not recovered from major side effects.
15. Patient is currently receiving warfarin or other Coumadin derived
anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with
heparin, low molecular weight heparin (LMWH), or fondaparinux is
allowed.
16. Patient is currently receiving or has received systemic
corticosteroids = 2 weeks prior to starting study drug, or who have not
fully recovered from side effects of such treatment.
17. Patient is concurrently using other antineoplastic agents (except for
patients who are receiving = 14 days of tamoxifen or NSAI or goserelin
<= 28 days for advanced breast cancer
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer
MedDRA version: 21.1
Level: LLT
Classification code 10072737
Term: Advanced breast cancer
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: ribociclib Product Code: LEE011 Pharmaceutical Form: Capsule, hard INN or Proposed INN: ribociclib CAS Number: 1374639-75-4 Current Sponsor code: LEE011 Other descriptive name: LEE011 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Trade Name: Letrozole Product Name: letrozole Pharmaceutical Form: Tablet INN or Proposed INN: LETROZOLE CAS Number: 112809-51-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5-
Trade Name: Tamoxifen Product Name: Nolvadex Pharmaceutical Form: Tablet INN or Proposed INN: tamoxifen CAS Number: 10540-29-1 Other descriptive name: TAMOXIFEN CITRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Trade Name: anastrazole Product Name: Arimidex Pharmaceutical Form: Tablet INN or Proposed INN: anastrozole CAS Number: 120511-73-1 Other descriptive name: ANASTROZOLE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: median PFS of 13.4 months
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Primary end point(s): PFS per local assessment and RECIST 1.1
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Main Objective: To determine whether treatment with tamoxifen/NSAI + goserelin + LEE011 prolongs PFS compared to treatment with tamoxifen/NSAI + goserelin + placebo in premenopausal women with HR+, HER2-negative breast cancer
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Secondary Objective: Key secondary: To determine whether treatment with tamoxifen/NSAI + goserelin + LEE011 prolongs OS compared to treatment with tamoxifen/NSAI + goserelin + placebo
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Secondary Outcome(s)
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Secondary end point(s): Key secondary:
Overall Survival (OS)
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Timepoint(s) of evaluation of this end point: median OS of 47 months
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Secondary ID(s)
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2014-001931-36-HU
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CLEE011E2301
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date: 21/01/2015
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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