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Breast CancerPhase 3MONARCH plusNCT02763566

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

A Phase 3 study testing Abemaciclib, Anastrozole and Letrozole in people with Breast Cancer, run by Eli Lilly and Company at 45 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Abemaciclib, Anastrozole and Letrozole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
463 participants
Where
45 sitesin 4 countries
Study dates
5 Dec 2016to Mar 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of HR+, HER2- breast cancer. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status if clinically indicated.
  • To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least 1 of the HRs (estrogen receptor [ER], progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
  • To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined in the relevant ASCO/CAP guidelines.
  • Meet either Inclusion Criterion (2a) or Inclusion Criterion (2b). Participants meeting Inclusion Criterion 2a will be enrolled in Cohort A and participants meeting Inclusion Criterion 2b will be enrolled in Cohort B.
  • (2a) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.
  • Relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease (Note: prior adjuvant endocrine therapy for localized disease may have included, but is not limited to, anti-estrogens or aromatase inhibitors. In addition, a participant may be enrolled if she has received ≤2 weeks of NSAI in this disease setting immediately preceding screening and agrees to discontinue NSAI until study treatment initiation.) OR
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  • Presented with de novo metastatic breast cancer (mBC) and not received any prior endocrine therapy. OR
  • Relapsed with radiologic evidence of progression less than 1 year from completion of or while receiving adjuvant endocrine therapy (except for letrozole or anastrozole) and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease.
  • (2b) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.
  • Relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR
  • Relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR
  • Relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as firstline endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease OR
  • Presented with de novo metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease.
  • Have postmenopausal status defined as meeting at least 1 of the following:
  • Prior bilateral oophorectomy
  • Age ≥60 years
  • Age <60 years and amenorrheic for at least 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone (FSH) and estradiol levels in the postmenopausal range.
  • Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1:
  • Measurable disease
  • Nonmeasurable bone-only disease. Nonmeasurable bone-only disease may include any of the following: blastic bone lesions, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component.
  • Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology (ECOG) scale.
  • Have adequate organ function, including:
  • Hematologic: absolute neutrophil count (ANC) ≥1.5 × 109/Liter (L), platelets
  • ≥100 × 109/L, and hemoglobin ≥8 g/deciliter (dL). Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the erythrocyte transfusion.
  • Hepatic: Total bilirubin ≤1.5 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
  • ≤3.0 times ULN (or ALT and AST ≤5 times ULN if liver metastases are present).
  • Renal: serum creatinine ≤1.5 times ULN.
  • Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization 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.
  • Are able to swallow capsules.
  • Are reliable, willing to be available for the duration of the study, and willing to follow study procedures.

Who cannot join

  • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
  • Have inflammatory breast cancer.
  • Have clinical evidence or a history of central nervous system (CNS) metastasis. Screening test is not required for enrollment.
  • Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. (Note: Participants may be enrolled if they received prior [neo]adjuvant chemotherapy for localized disease.)
  • Have received prior treatment with everolimus or fulvestrant (for Cohort B only).
  • Have received prior treatment with any cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitor (or participated in any CDK4 and CDK6 inhibitor clinical trial for which treatment assignment is still blinded).
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  • Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization.
  • Are currently enrolled in a clinical trial involving an investigational product (IP) or non-approved use of a drug or device (other than the IP/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. If a participant is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the investigator and Eli Lilly and Company (Lilly) clinical research physician (CRP) is required to establish eligibility.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively.
  • Have had major surgery within 14 days prior to randomization to allow for post-operative healing of the surgical wound and site(s).
  • Have received recent (within 28 days prior to randomization) live attenuated vaccines such as yellow fever vaccine.
  • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (eg, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis).
  • Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
  • Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
  • Have received an autologous or allogeneic stem-cell transplant.
  • Have clinical evidence of active bacterial or fungal infection or active viral infection that, in the judgment of the investigator, would preclude participation in this study (eg, human immunodeficiency virus [HIV] or viral hepatitis). Screening test is not required for enrollment.

Trial locations and contacts

45 sites in 4 countries.

45 sites in 4 countries

China28 sites

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Afflilated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Jilin Province Tumor Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The 2nd Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • Fujian Provincial Cancer hospital

    Fuzhou, Fujian, 350014

  • Fuzhou General hospital of Nanjing Military Command

    Fuzhou, Fujian, 350025

  • Guangdong Province People's Hospital

    Guangzhou, Guangdong, 510080

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The Second Affiliate Hospital of Zhejiang University School of medicine

    Hangzhou, Zhejiang, 310052

  • Harbin Medical University Caner Hospital

    Harbin, Heilongjiang, 150081

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Liaoning Cancer Hospital&Institute

    Shenyang, Liaoning, 100042

  • The first affiliated hospital of China medical university

    Shenyang, Liaoning, 110001

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50035

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • Wuhan Union Hospital Cancer Center

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical, Science & Technology

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

India8 sites

  • The Gujarat Cancer & Research Institute (GCRI)

    Ahmedabad, Gujarat, 380016

  • Healthcare Global Enterprises Limited (HCG)

    Bangalore, Karnataka, 560027

  • M S Ramaiah Medical College Hospitals

    Bangalore, Karnataka, 560054

  • Medica Superspecialty Hospital

    Kolkata, West Bengal, 700099

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400 012

  • Dr. B. L. Kapur Memorial Hospital

    New Delhi, National Capital Territory of Delhi, 110005

  • Jehangir Hospital

    Pune, Maharashtra, 411001

  • Christian Medical College Vellore

    Ranipet, Tamil Nadu, 632513

Other trials in India

Brazil6 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, Rio Grande do Sul, 98700 000

  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15091-000

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

  • Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA

    São Paulo, 01317-000

Other trials in Brazil

South Africa3 sites

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Sandton Oncology Centre

    Johannesburg, 2196

  • Eastleigh Breast Care Center

    Pretoria, Gauteng, 0081

Other trials in South Africa

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer

The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.

Conditions
Breast Cancer
Keywords
Hormone Receptor-Positive, HER2-Negative, CDK4, CDK6
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02763566
Study groupRoleWhat they receive
Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)ExperimentalAbemaciclib given orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle. Participants receiving benefit may continue until disease progression.
Receives: Drug: Abemaciclib; Drug: Anastrozole; Drug: Letrozole
Placebo + NSAIExperimentalPlacebo given orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle. Participants receiving benefit may continue until disease progression.
Receives: Drug: Anastrozole; Drug: Letrozole; Drug: Placebo
Abemaciclib + FulvestrantExperimentalAbemaciclib given orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond. Participants receiving benefit may continue until disease progression.
Receives: Drug: Abemaciclib; Drug: Fulvestrant
Placebo + FulvestrantExperimentalPlacebo given orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond. Participants receiving benefit may continue until disease progression.
Receives: Drug: Placebo; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)

    Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. 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. Patients 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.

    Measured: Randomization to Measured Progressive Disease or Death (up to 26 Months)

Secondary outcomes (8)

  1. Progression Free Survival (PFS) (Abemaciclib + Fulvestrant and Placebo + Fulvestrant Arms)

    Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. 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. Patients 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.

    Measured: Randomization to Measured Progressive Disease or Death (up to 26 Months)

  2. Overall Survival (OS)

    Measured: Randomization to Date of Death from Any Cause (Estimated up to 38 Months)

  3. Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

    Objective response rate is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is 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.

    Measured: Randomization to Measured Progressive Disease (up to 26 Months)

  4. Duration of Response (DoR)

    Measured: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 38 Months)

  5. Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]

    Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.

    Measured: Randomization to Measured Progressive Disease (up to 26 Months)

  6. Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]

    Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD for at least 6 months. CR is defined as the disappearance of all target and non-target lesions \& no appearance of new lesions. PR is 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. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.

    Measured: Randomization to Measured Progressive Disease (up to 26 Months)

  7. Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

    consists of 30 items covered by 1 of 3 dimensions:

    1. Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).
    2. 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)
    3. 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.

    Measured: Baseline through 19 Months

  8. Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20)

    Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib and its Metabolites LSN2839567 (M2) \& LSN3106726 (M20) was reported.

    C=Cycle, D=day;

    Measured: C1D1 post dose, C2D1 post dose, C3D1 predose, C4D1 predose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2016 (estimated)
  2. Study start5 Dec 2016
  3. Primary completion29 Mar 2019
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02763566
Sponsor's protocol ID
15530
Other IDs
I3Y-CR-JPBQ
Acronym
MONARCH plus
Status last verified
Jan 2026
First submitted
4 May 2016
Last updated
5 Feb 2026
Data monitoring committee
Yes

Publications

  • Hu X, Zhang Q, Sun T, Yin Y, Li H, Yan M, Tong Z, Li M, Teng Y, Oppermann CP, Kanakasetty GB, Portugal MC, Yang L, Zhang W, Jiang Z. Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2- advanced breast cancer: Final results of the randomized phase III MONARCH plus trial. Chin Med J (Engl). 2025 Jun 20;138(12):1477-1486. doi: 10.1097/CM9.0000000000003151. Epub 2024 Oct 10.

    PubMed 39385327

  • Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, Oppermann CP, Liu YP, Costa R, Li M, Cheng Y, Ouyang QC, Chen X, Liao N, Wu XH, Wang XJ, Feng JF, Hegg R, Kanakasetty GB, Coccia-Portugal MA, Han RB, Lu Y, Chi HD, Jiang ZF, Hu XC. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 Oct 22;12:1758835920963925. doi: 10.1177/1758835920963925. eCollection 2020.

    PubMed 33149768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abemaciclib, Anastrozole and Letrozole in people with Breast Cancer, run by Eli Lilly and Company at 45 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in China, India, Brazil, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI) (time frame: Randomization to Measured Progressive Disease or Death (up to 26 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02763566, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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