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Trial record 6 of 22 for:    cancer | First posted from 04/21/2016 to 04/21/2016

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02747004
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Abemaciclib Drug: Tamoxifen Drug: Prophylactic Loperamide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Abemaciclib + Tamoxifen
Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Tamoxifen
Administered orally
Experimental: Abemaciclib
Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Experimental: Abemaciclib + Prophylactic Loperamide
Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Prophylactic Loperamide
Administered orally


Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Disease Progression or Death from Any Cause (Approximately 14 Months) ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Objective Disease Progression (Approximately 14 Months) ]
  2. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 14 Months) ]
  3. Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 36 Months) ]
  4. Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and its Metabolites [ Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) ]
  5. PK: Mean Steady State Exposure of Tamoxifen and Endoxifen [ Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) ]
  6. Change from Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) [ Time Frame: Baseline, End of Study (Approximately 14 Months) ]
  7. Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) [ Time Frame: Baseline, End of Study (Approximately 14 Months) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of HR+, HER2- breast cancer.
  • Relapsed or progressed following endocrine therapy.
  • Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.
  • Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.
  • Have adequate organ function.
  • Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment.
  • Are able to swallow oral medication.

Exclusion Criteria:

  • Have clinical evidence or history of central nervous system metastasis.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
  • Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s).
  • Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
  • Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection.
  • Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor.
  • Have a preexisting chronic condition resulting in persistent diarrhea.
  • Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.
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): NCT02747004


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 60 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02747004     History of Changes
Other Study ID Numbers: 16339
I3Y-MC-JPCG ( Other Identifier: Eli Lilly and Company )
2016-000288-18 ( EudraCT Number )
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Loperamide
Antidiarrheals
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Gastrointestinal Agents