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Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02278120
First Posted: October 29, 2014
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

Condition Intervention Phase
Advanced, Metastatic Breast Cancer Drug: LEE011 Drug: Tamoxifen Drug: Letrozole Drug: Anastrozole Drug: Goserelin Drug: LEE011 Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Up to approximatley 25 months ]
    PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause and assessed according to RECIST 1.1


Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to approximately 69 months ]
    Time from date of randomization to the date of death from any cause

  • Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 25 months ]
    Proportion of patients with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1

  • Safety and Tolerability of LEE011 [ Time Frame: Up to approximately 26 months ]
    Safety and tolerability will be determined by type, frequency and severity of adverse events and laboratory abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

  • Time to Response (TTR) [ Time Frame: Up to approximately 25 months ]
    Time from randomization to the first documented and confirmed response (complete response or partial response)

  • Duration of Response (DOR) [ Time Frame: Up to approximately 25 months ]
    Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer

  • Time to definitive deterioration of the ECOG PS from baseline [ Time Frame: Baseline, up to approximately 25 months ]
    Time to deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

  • Time to 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 [ Time Frame: Up to approximately 25 months ]
    Patient reported outcomes for health related quality of life

  • Change from baseline in the global health status/QOL scale score of the EORTC QLQ-C30 [ Time Frame: Up to approximately 25 months ]
    Patient reported outcomes for health related quality of life

  • Overall Response Rate (ORR) [ Time Frame: Up to approximately 25 months ]
    Proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.


Enrollment: 672
Actual Study Start Date: November 21, 2014
Estimated Study Completion Date: February 27, 2018
Estimated Primary Completion Date: February 27, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEE011 + NSAI/tamoxifen + goserelin
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
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
Placebo Comparator: LEE011 placebo + NSAI/tamoxifen+ goserelin
LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
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

Detailed Description:
The purpose of this study is to assess the efficacy of LEE011, as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278120


  Show 204 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02278120     History of Changes
Other Study ID Numbers: CLEE011E2301
First Submitted: October 22, 2014
First Posted: October 29, 2014
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HR-positive
HER2-negative
Advanced breast cancer
Letrozole
Anastrozole
Tamoxifen
Goserelin
CDK
CDK4
CDK6
CDK4/6
Phase III
ER-positive
PR-positive
Premenopausal

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Letrozole
Anastrozole
Tamoxifen
Goserelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents