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NCT Number: NCT02747004

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

CENIT Centro de Neurociencias, Investigación y Tratamiento, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 3 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 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.

Treatment and study plan

Abemaciclib

Drug

Administered orally

Other names: LY2835219

Tamoxifen

Drug

Administered orally

Prophylactic Loperamide

Drug

Administered orally

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)

    Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.

Secondary outcomes

  1. Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

    Time frame: Baseline to Objective Disease Progression (Up to 21 Months)

    Objective response rate was defined as the percentage of participants with CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD (longest diameter) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

  2. Duration of Response (DoR)

    Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months)

    DoR is defined as the time from the date of first evidence of a CR or PR to the date of objective progression or death from any cause, whichever is earlier as defined by Recist v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

  3. Overall Survival (OS)

    Time frame: Baseline to Death from Any Cause (Approximately 36 Months)

  4. Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites

    Time frame: Cycle (C) 1 Day (D) 1 post dose

    Mean single dose concentrations of Abemaciclib and its metabolites (M2 & M20) are reported.

  5. Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites

    Time frame: Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose

    Mean steady state concentrations of Abemaciclib and its metabolites (M2 & M20) are reported.

    C=Cycle D= Day

  6. PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen

    Time frame: Cycle 1 Day 1 post dose

    Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.

  7. PK: Multiple Dose Concentration of Tamoxifen and Endoxifen

    Time frame: Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose

    Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.

  8. 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, 21 Months

    The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:

    • Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).
    • Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)
    • Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).

    Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.

  9. Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

    Time frame: Baseline, 21 Months

    mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours and typical completion time for this instrument is less than 5 minutes.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: Next MONARCH 1

Important dates

Study start
2016
Primary completion
2018
Study completion
2026
First posted
Apr 21, 2016
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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