A phase III randomized , double blind, placebo controlled study of LEE011or 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, HER 2 negative, advanced breast cancer. ( MONALEESA 7)

• Register: LBCTR
• Last refreshed on: 21 October 2024
• Main ID: LBCTR2019020194
• Date of registration: 29/09/2023
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services Inc.
• Public title: A phase III randomized , double blind, placebo controlled study of LEE011or 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, HER 2 negative, advanced breast cancer. ( MONALEESA 7)
• Scientific title: A phase III randomized , double blind, placebo controlled study of LEE011or 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, HER 2 negative, advanced breast cancer.
• Date of first enrolment: 24/03/2015
• Target sample size: 28
• Recruitment status: Complete
• URL: https://lbctr.moph.gov.lb/Trials/Details/5440
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial;Masking: Blinded (masking used);Control: Placebo;Assignment: Parallel;Purpose: Treatment
• Phase: 3

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, France, Germany, Greece, Hungary, India, Italy, Lebanon, Malaysia, Mexico, Poland, Portugal, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates, United States of America

Contacts

• Name: Hind Khairallah
• Affiliation: Khalil Fattal et Fils s.a.l.

• Name: Fadi Farhat
• Affiliation: Hammoud Hospital

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria:
•Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
•Patient is premenopausal or perimenopausal at the time of study entry
•Patients who received (neo) adjuvant therapy for breast cancer are eligible
•Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
•Patient has HER2-negative breast cancer
•Patient must have either measurable disease or If no measurable disease is present, then at least one predominantly lytic bone lesion
•Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Patient has adequate bone marrow and organ function

Exclusion criteria: Exclusion Criteria:
•Patient who has received a prior CDK4/6 inhibitor
•Patient is postmenopausal
•Patients who currently have inflammatory breast cancer at screening.
•Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for = 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
•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.
•Patient with CNS metastases.
•Patient has active cardiac disease or a history of cardiac dysfunction
•Patient is currently using other antineoplastic agents
•Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception

Other protocol-defined Inclusion/Exclusion may apply.


Age minimum: 18
Age maximum: 59
Gender: Female

Health Condition(s) or Problem(s) studied

Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Premenaupausal advanced breast cancer

Premenaupausal advanced breast cancer

C50.9

Intervention(s)

•Drug: LEE011
LEE011 600 mg daily oral

•Drug: Tamoxifen
tamoxifen 20 mg daily oral

•Drug: Letrozole
letrozole 2.5 mg daily oral

•Drug: Anastrozole
anastrozole 1 mg daily oral

•Drug: Goserelin
Goserelin 3.6 mg subcutaneous injection

•Drug: LEE011 Placebo
LEE011 placebo 600 mg daily oral

Informed consent / patient history / drug administration / Lab tests

ICF, IMP, Lab tests and ECG , diary completion

Primary Outcome(s)

Name: Progression Free Survival;Timepoints: 25 months;Measure: 25 months

Secondary Outcome(s)

Name: Safety and Tolerability of LEE011;Timepoints: 26 Months;Measure: 26 Months

Name: Overall survival;Timepoints: 69 Months;Measure: up to 69 Months

Secondary ID(s)

NCT02278120

Source(s) of Monetary Support

Novartis Pharma Services Inc.

Ethics review

Status: Approved
Approval date: 21/10/2014
Contact:

[e-mail]

Hammoud Hospital University Medical Center

[phone] ext 1160

[e-mail]

Status: Approved
Approval date: 28/10/2014
Contact:

[e-mail]

Bellevue Medical Center

[phone] ext 5006

[e-mail]

Status: Approved
Approval date: 05/11/2014
Contact:

[e-mail]

Hotel Dieu de France

961421229

[e-mail]

Status: Approved
Approval date: 29/01/2015
Contact:

[e-mail]

Saint George Hospital University Medical Center

[phone]

[e-mail]

Status: Approved
Approval date: 26/02/2015
Contact:

[e-mail]

American University of Beirut Medical Center

[phone] ext:5445

[e-mail]

Status: Approved
Approval date: 29/05/2015
Contact:

[e-mail]

Ain w Zein Medical Village

[phone] ext 2014

[e-mail]

Results

• Results available: Yes
• Date Completed: 12/01/2016