ClinicalTrials.gg
CompletedNCT03477396Updated Feb 20, 2024Results posted

Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer

A Phase 2 interventional study of Aromatase Inhibitor and Laboratory Biomarker Analysis in Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative and Stage IV Breast Cancer AJCC v6 and v7, sponsored by City of Hope Medical Center. Completed at 9 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 349 studies testing Aromatase inhibitors in Breast Neoplasms — 53 open to participants now, 81 under way, 22 of them phase 3. A drug class: Aromatase inhibitors · Breast Neoplasms.

Enrollment
330th of 341
2 · median 112
Started
2018
with 12 others
Phase 2
166 of 349
36 open now
Registered
260th of 349
by date

Among the 349 studies testing Aromatase inhibitors in Breast Neoplasms, this one is the 330th largest by enrollment of the 341 interventional ones that give a count, is one of 13 that started in 2018, is one of 166 in phase 2, and was the 260th registered.

Breast Neoplasms

14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

53 of the 349 studies testing Aromatase inhibitors in Breast Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

48 more — sign in →

By country, each count listing its studies:

All 53 open studies →

About Aromatase inhibitors

A class of medicines: which ones, and the studies of each, are on its page →

Who these studies take

Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 70 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 349 studies testing Aromatase inhibitors in Breast Neoplasms, or all of them as a file.
02

Study summary

This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body. Ribociclib and aromatase inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

I. To estimate the safety and tolerability of the combination of ribociclib and an aromatase inhibitor in adults age 70 or older with hormone receptor positive metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To describe the full toxicity profile including all grades. II. To estimate the rate of worst grades of myelosuppression (neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal (GI) side effects (nausea, diarrhea, decreased appetite, vomiting, stomatitis), fatigue, neuropathy, and thromboembolism.

III. To describe rates of dose reductions, dose holds, and hospitalizations. IV. To estimate objective response rate and clinical benefit rate as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) criteria.

V. To estimate median progression-free and overall survival.

EXPLORATORY OBJECTIVES:

I. To estimate the rate of adherence to ribociclib. II. To explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

III. To describe the results of the Was It Worth It (WIWI) and the results of the Overall Treatment Utility (OTU) Questionnaires.

OUTLINE:

Participants receive ribociclib orally (PO) once daily (QD) on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days, then annually thereafter.

03

Conditions studied

  • Estrogen Receptor and/or Progesterone Receptor Positive
  • HER2/Neu Negative
  • Stage IV Breast Cancer AJCC v6 and v7

Browse trials for

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient has signed the (ICF) prior to any study procedures being performed and is able to comply with protocol requirements
  • Must be able to swallow ribociclib
  • Age: >= 70 years at time of enrollment >= 70 to \< 74 years, >= 75 years

    * NOTE: A minimum of 20 participants must be >= 75 years. The remaining 20 participants may be >= 70 to \< 74 years OR >= 75 years

  • Subjects must be able to communicate with the investigator and comply with the requirements of the study procedures
  • Patient has a and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer, -negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+, and breast cancer
  • First or endocrine therapy for metastatic disease. One prior line of chemotherapy for metastatic disease is allowed
  • >= 1.5 x 10\^9 /L, at screening
  • >= 100 x 10\^9 /L, at screening
  • >= 9.0 g/dL, at screening
  • Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplement before the first dose of study medication:

    • Sodium
    • Potassium
    • Magnesium
    • Total calcium (corrected for serum albumin)
    • Phosphorous
  • Serum creatinine \< 1.5 mg/dL or >= 50 mL/min, at screening
  • In the absence of liver metastases, (ALT) and aspartate aminotransferase (AST) \< 2.5 x (ULN); if the patient has liver metastases, ALT and AST \< 5 x ULN, at screening
  • Total \< ULN; or total bilirubin =\< 3.0 x ULN or direct bilirubin =\< 1.5 x ULN in patients with well-documented Gilbert's syndrome, at screening
  • Patient with available standard 12-lead (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):

    • Fridericia's (QTcF) interval at screening \< 450msec (using Fridericia's correction)
    • Resting heart rate 50-90 beats per minute (bpm)

Exclusion criteria

Exclusion Criteria:

  • Patient received prior treatment with any CDK4/6 inhibitor
  • Patient has a known to any of the of ribociclib
  • Patients with a prior diagnosed within 2 years AND with evidence of disease (except adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer)
  • Patient with concurrent malignancy that is not clinically stable AND needs tumor-directed therapy
  • Patients with central nervous system (CNS) involvement unless they meet ALL the following criteria:

    • Untreated (e.g., lesions \< 1cm) not needing immediate local therapy
    • Previously treated brain metastases not needing immediate local therapy

      • At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
      • Clinically stable CNS tumor at the time of screening and not receiving and/or enzyme-inducing anti-epileptic medications for brain metastases
  • , uncontrolled heart disease and/or cardiac repolarization abnormalities, including any of the following:

    • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening
    • Documented cardiomyopathy
    • Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block).
    • Long syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

      • Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
      • Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication
      • Inability to determine the QT interval on screening (QTcF, using Fridericia's correction)
    • Systolic blood pressure (SBP) > 160 mmHg or \< 90 mmHg at screening
  • Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:

    • Known strong inducers or inhibitors of /5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges
    • That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
    • Herbal preparations/medications, dietary supplements
    • Warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), newer anticoagulation agents such as direct factor Xa inhibitors, or fondaparinux is allowed
  • Patient is currently receiving or has received systemic corticosteroids =\< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment

    * The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)

  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
  • Participation in a prior study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
  • Patient has had major surgery and/or radiotherapy within 14 days prior to starting study drug or has not recovered from major side effects (tumor is not considered as major surgery)
  • Patient with a score B or C
  • Patient has not recovered from the acute effects of prior systemic therapy (until the toxicity resolves to either baseline or at least grade 1) except for residual alopecia or peripheral neuropathy
  • Patient has a history of non-compliance to medical regimen or inability to grant consent
  • Sexually active males unless they use a condom during intercourse while taking the drug and for 21 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Treatment (ribociclib, aromatase inhibitor)

    Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Drug: Aromatase Inhibitor · Other: Laboratory Biomarker Analysis · Other: Pharmacokinetic Study · Other: Questionnaire Administration · Drug: Ribociclib

Interventions

  • Aromatase inhibitor per treating investigator's discretion

    Also known as: Androstenedione Aromatase Inhibitor, Estrogen Synthase Inhibitor, Estrogen Synthetase Inhibitor

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPharmacokinetic Study

    Correlative studies

    Also known as: PHARMACOKINETIC, PK Study

  • OtherQuestionnaire Administration

    Ancillary studies

  • Given PO

    Also known as: Kisqali, LEE-011, LEE011

06

What researchers measure

Primary outcomes

  1. Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib

    Number of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib

    Time frame: Up to 30 days of last study drug, about 3 years and 3 months

Secondary outcomes

  1. Number of Participants With Dose Reductions

    Time frame: Up to 3.5 years

  2. Number of Participants With Dose Delays

    Time frame: Up to 3.5 years

  3. Number of Participants With Dose Discontinuations

    Time frame: Up to 3.5 years

  4. Objective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    Objective response rate (defined as complete response \[CR\] + partial response \[PR\]) as determined by RECIST criteria Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

    Time frame: Up to 3.5 years

  5. Clinical Benefit Rate as Determined by RECIST

    Clinical benefit rate (defined as CR+PR+ stable disease) as determined by RECIST Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

    Time frame: Up to 3.5 years

07

Results

Posted May 18, 2022

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Ribociclib, Aromatase Inhibitor)
Started2
Completed2
Not completed0

Outcome measures

PrimaryNumber of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib

Number of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib

Time frame:
Up to 30 days of last study drug, about 3 years and 3 months
Reported as:
Count of participants · Participants
Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib
ParticipantsTreatment (Ribociclib, Aromatase Inhibitor)
Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib2
SecondaryNumber of Participants With Dose Reductions
Time frame:
Up to 3.5 years
Reported as:
Count of participants · Participants
Number of Participants With Dose Reductions
ParticipantsTreatment (Ribociclib, Aromatase Inhibitor)
Number of Participants With Dose Reductions2
SecondaryNumber of Participants With Dose Delays
Time frame:
Up to 3.5 years
Reported as:
Count of participants · Participants
Number of Participants With Dose Delays
ParticipantsTreatment (Ribociclib, Aromatase Inhibitor)
Number of Participants With Dose Delays2
SecondaryNumber of Participants With Dose Discontinuations
Time frame:
Up to 3.5 years
Reported as:
Count of participants · Participants
Number of Participants With Dose Discontinuations
ParticipantsTreatment (Ribociclib, Aromatase Inhibitor)
Number of Participants With Dose Discontinuations2
SecondaryObjective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

Objective response rate (defined as complete response \[CR\] + partial response \[PR\]) as determined by RECIST criteria Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Time frame:
Up to 3.5 years
Reported as:
Count of participants · Participants
Objective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
ParticipantsTreatment (Ribociclib, Aromatase Inhibitor)
Objective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria1
SecondaryClinical Benefit Rate as Determined by RECIST

Clinical benefit rate (defined as CR+PR+ stable disease) as determined by RECIST Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Time frame:
Up to 3.5 years
Reported as:
Count of participants · Participants
Clinical Benefit Rate as Determined by RECIST
ParticipantsTreatment (Ribociclib, Aromatase Inhibitor)
Clinical Benefit Rate as Determined by RECIST2

Adverse events

Collected over Up to 30 days post cycle, up to 3.5 years total. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Ribociclib, Aromatase Inhibitor)1/2 (50%)0/2 (0%)2/2 (100%)
Most frequent other events
Showing 10 of 44
Most frequent other events
EventTreatment (Ribociclib, Aromatase Inhibitor)
NauseaGastrointestinal disorders2/2
FatigueGeneral disorders2/2
Alanine aminotransferase increasedInvestigations2/2
Alkaline phosphatase increasedInvestigations2/2
Aspartate aminotransferase increasedInvestigations2/2
Neutrophil count decreasedInvestigations2/2
White blood cell decreasedInvestigations2/2
HyponatremiaMetabolism and nutrition disorders2/2
CoughRespiratory, thoracic and mediastinal disorders2/2
AnemiaBlood and lymphatic system disorders1/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (Ribociclib, Aromatase Inhibitor)
<=18 years0
Between 18 and 65 years0
>=65 years2
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Ribociclib, Aromatase Inhibitor)
Female2
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Ribociclib, Aromatase Inhibitor)
Hispanic or Latino0
Not Hispanic or Latino2
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Ribociclib, Aromatase Inhibitor)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Ribociclib, Aromatase Inhibitor)
United States2
Karnofsky Status
Karnofsky Status(Participants)Treatment (Ribociclib, Aromatase Inhibitor)
100 - Normal no complaints; no evidence of disease1
90 - Able to carry on normal activity; minor signs or symptoms of disease1
08

Study locations

9 sites
  • City of Hope Corona
    Corona, California 92879, United States
  • City of Hope Medical Center
    Duarte, California 91010, United States
  • City of Hope Antelope Valley
    Lancaster, California 93534, United States
  • City of Hope Mission Hills
    Mission Hills, California 91345, United States
  • City of Hope Rancho Cucamonga
    Rancho Cucamonga, California 91730, United States
  • City of Hope South Pasadena
    South Pasadena, California 91030, United States
  • City of Hope West Covina
    West Covina, California 91790, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Wilmot Cancer Institute
    Rochester, New York 14642, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Sep 2021, 39 months.

Results were first posted in May 2022, 7 months after primary completion.

Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 89. This study's 39 months is below that.

Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2018
First posted
Mar 26, 2018
StartActual
Jun 14, 2018
Primary completionActual
Sep 29, 2021
CompletionActual
Jun 5, 2023
Results first posted
May 18, 2022
Last update
Feb 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03477396
Responsible party
Sponsor
First posted
Mar 26, 2018
Start date
Jun 14, 2018
Primary completion
Sep 29, 2021
Completion
Jun 5, 2023
Results posted
May 18, 2022
Last update
Feb 20, 2024

Study contacts

Mina Sedrak, MD
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Aromatase inhibitors · Ribociclib

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