Breast CancerPhase 2NCT06001762
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
A Phase 2 study testing Abemaciclib, Tamoxifen and Anastrozole in people with Breast Cancer and Early-stage Breast Cancer, run by Dana-Farber Cancer Institute at 12 sites in United States.
Trial summary
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive 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, Early-stage Breast Cancer, High Risk Breast Carcinoma
- What is being tested?
- Abemaciclib, Tamoxifen and Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 12 sitesUnited States
- Study dates
- 5 Oct 2023to 1 Jan 2027
- Phase
- Phase 2
- 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
- Stage II or III node-positive HR+/HER2- breast cancer per local laboratory assessment.
- Eligible participants must be appropriate candidates for adjuvant abemaciclib, per assessment of their treating physician.
- Participants must be candidates for adjuvant endocrine therapy, which may have started before or at time of entry onto the trial. Patient may be receiving adjuvant aromatase inhibitor or tamoxifen, +/- ovarian suppression.
- Participants must have undergone definitive surgery of the primary breast tumor(s) within 16 months of study entry.
- At least 21 days must have elapsed between last dose of chemotherapy and registration. Participants who previously received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization.
- At least 14 days must have elapsed between end of radiotherapy and day 1 of treatment with abemaciclib. Participants who received prior radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. No radiotherapy should be planned to occur during study therapy.
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- At least 14 days must have elapsed since most recent breast surgery prior to registration and patient has recovered from side effects of prior surgery.
- Bilateral or multifocal/multicentric breast cancers that meet eligibility criteria are allowed.
- ECOG performance status 0-1
- Men and women with any menopausal status ≥18 years of age
- Adequate organ function as defined below:
- Absolute neutrophil count (ANC) ≥ 1500 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 8g/dL; patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
- Bilirubin ≤ 1.5 x ULN. For patients with Gilbert syndrome, the limit is ≤ 2 x institutional ULN AND direct bilirubin within the normal range of normality.
- AST/ALT ≤ 3 x institutional ULN
- Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female patients who are:
- Age > 60 years; or
- Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more AND FSH/estradiol levels within postmenopausal range; or
- Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation.
- Women of child-bearing potential and men with partners of childbearing potential must be willing to employ one highly effective form of nonhormonal contraception (with the exception of hormonal IUDs) or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 3 months after the last dose of abemaciclib.
- Subject must be able to swallow and retain oral medication.
- Ability to understand and the willingness to sign a written informed consent document.
- Non-English-speaking patients are eligible but will be exempt from patient-completed questionnaires.
Who cannot join
- Prior treatment with any CDK4/6 inhibitor.
- Patients with node-negative breast cancer are not eligible for the trial.
- Concurrent therapy with other investigational agents.
- Diagnosis of inflammatory breast cancer (T4d).
- History of allergic reactions attributed to abemaciclib or similar chemical or biologic composition or excipients.
- Participants with a history of malignancy are ineligible except in the following circumstances:
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- --Individuals with a history of invasive breast cancer are not eligible unless they have been disease-free for a minimum of five years.
- Individuals with a malignancy history other than invasive breast cancer are eligible if they have no active malignancy and are deemed by the investigator to be at low risk for recurrence of that malignancy.
- Individuals with the following cancer history are eligible: adequately treated non- melanoma skin cancers, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma. Other exceptions may exist following review with the sponsor-investigator
- Serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting uncontrolled Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) or other conditions that in the opinion of the investigator limit compliance with study requirements.
- History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- Any of the following due to teratogenic potential of the study drugs:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDS, surgical sterilization, abstinence, etc). Hormonal birth control methods are not permitted.
- Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc).
- Receipt of an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor-investigator not to be scientifically or medically compatible with this study.
- Active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment) or invasive/ systemic fungal infection\
- For patients with known HIV infection, CD4 baseline count should be evaluated: patients with a CDK count ≥ 350 cells/uL can be enrolled. Participants should be on established anti-retroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment. Potential pharmacological interactions of the ART with abemaciclib and endocrine therapy must be reviewed, particularly for the effects on CYP3A4.
- Patients with active or chronic Hepatitis B or C are eligible provided they meet liver function laboratory criteria and cannot be on any medication with a known interaction with the study agents.
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4, including selected herbals (e.g., hypericum) and food (e.g., grapefruit) known for pharmacological interactions, cannot be enrolled, due to interference with the dose-escalation, unless the food or supplement has been discontinued at least after an interval equivalent to 3-5 half-lives of the inhibitor.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Eastern Maine Medical Center (Northern Light)
Brewer, Maine, 04412
Dana-Farber Cancer Institute at Steward St. Elizabeth's
Brighton, Massachusetts, 02135
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
Dana-Farber Cancer Insitute at Londonderry Hospital
Londonderry, New Hampshire, 03053
Dana-Farber Cancer Institute at Merrimack Valley
Methuen, Massachusetts, 01844
Dana-Farber Cancer Institute at Milford
Milford, Massachusetts, 01757
New England Cancer Specialists
Scarborough, Maine, 04074
Dana-Farber Cancer Institute at South Shore
South Weymouth, Massachusetts, 02190
Stamford Hospital
Stamford, Connecticut, 06904
About this study
Official title: The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer.
The names of the study drugs involved in this study are:
- Abemaciclib (CDK4 and CDK6 inhibitor)
- Tamoxifen (Selective estrogen receptor modulator)
- Anastrozole/Letrozole (Non-steroidal aromatase inhibitors)
- Exemestane (steroidal aromatase inhibitor)
- LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
Read the detailed description
This research study is a prospective, single-arm, open label, phase 2 study designed to evaluate if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer.
This research study involves adjuvant abemaciclib plus endocrine (anti-hormone) therapy that works to target breast cancer. Adjuvant therapy is treatment given after surgery, chemotherapy, and/or radiation therapy.
The U.S. Food and Drug Administration (FDA) has approved abemaciclib as a treatment option for early-stage high-risk hormone receptor breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer.
The research study procedures include screening for eligibility, study treatment including laboratory evaluations and questionnaires, blood tests, tumor biopsies, and stool collections.
Participation in this research study is expected to last for at least 2 years and up to 5 years.
It is expected that about 90 people will take part in this research study.
Eli Lilly and Company is supporting this study by providing funding for the study and supplying the study drug, abemaciclib.
- Being tested
- Abemaciclib, Tamoxifen, Anastrozole, Letrozole, Exemestane
- Keywords
- Breast Cancer, Early-stage high-risk breast cancer, Early-stage breast cancer, High risk breast carcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
CDK4 and CDK6 inhibitor, tablet taken orally
TamoxifenDrug
Selective estrogen receptor modulator, taken orally per institutional standard of care
AnastrozoleDrug
Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
LetrozoleDrug
Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
ExemestaneDrug
Steroidal aromatase inhibitor, taken orally per institutional standard of care
LHRH AgonistDrug
Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
| Study group | Role | What they receive |
|---|---|---|
| Abemaciclib | Experimental | Study procedures will be conducted as follows:
* Cycles 1 - 24
* Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day.
* Endocrine therapy 1 x per day.
* In clinic visits with blood tests, questionnaires, and assessments:
* Day 1 of Cycles 1, 2, and 3
* Day 15 of Cycles 1 and 2
* Every three cycles after Cycle 3 Day 1.
* End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Receives: Drug: Abemaciclib; Drug: Tamoxifen; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: LHRH Agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks)
The composite endpoint is the number and proportion of participants with abemaciclib discontinuation for any reason and/or abemaciclib dose reductions and/or the inability of study participants to reach the target dose of abemaciclib (full dose 150 mg BID) at 3 months (12 weeks).
Measured: 3 months (12 weeks)
Secondary outcomes (16)
Number of Participants Unable to Reach Full Dose of Abemaciclib at 3 Months (12 Weeks)
Number of participants unable to reach the full dose (150 mg BID) of abemaciclib at 3 months (12 weeks)
Measured: 3 months (12 weeks)
Number of Participants Who Discontinued Abemaciclib Treatment for Any Reason at 12 Weeks
Number of participants who discontinued abemaciclib treatment for any reason 3 months (12 weeks)
Measured: 3 months (12 weeks)
Number of Participants With Abemaciclib Dose Reductions at 12 Weeks
Number of participants with abemaciclib dose reductions at 3 months (12 weeks)
Measured: 3 months (12 weeks)
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Weeks
Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent diarrhea adverse event reported per subject (across any dose level received) between the start of treatment and up to 24 weeks. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib.
Grade 0 - no toxicity reported
Grade 1 - mild
Grade 2 - moderate
Grade 3 - severe
Grade 4 - life-threatening
Grade 5 - fatal (no cases of grade 5 diarrhea to report)
Measured: Up to 24 weeks
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Adverse Events by 24 Weeks
Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent adverse event (of any kind) reported per subject (across any dose level received) between the start of treatment and up to 24 weeks. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib.
Grade 0 - no toxicity reported
Grade 1 - mild
Grade 2 - moderate
Grade 3 - severe
Grade 4 - life-threatening
Grade 5 - fatal (no cases of grade 5 toxicities)
Measured: Up to 24 weeks
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Weeks
The composite endpoint at 24 weeks is the number and proportion of participants with abemaciclib (abema) treatment discontinuations and/or abemaciclib dose reductions and/or participant inability to reach the target dose (full dose 150 mg BID) of abemaciclib at 24 weeks.
Measured: Up to 24 weeks
Number of Participants Unable to Reach the Full Dose by 24 Weeks
Number of participants unable to reach the full dose will be reported as the rate of participants who have never reached the full dose of abemaciclib at 150mg BID by 24 weeks.
Measured: Up to 24 weeks
Number of Participants Who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks
Number of Participants who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks (6 months)
Measured: Up to 24 weeks
Number of Participants With Abemaciclib Dose Reductions at 24 Weeks
Number of Participants with Abemaciclib Dose Reductions at 24 Weeks (6 months)
Measured: Up to 24 weeks
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Weeks
Number of participants who reached the full dose of abemaciclib (150mg BID) but then had a dose reduction by 24 weeks
Measured: Up to 24 weeks
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Months
The composite endpoint is the number and proportion of participants with abemaciclib discontinuation for any reason and/or abemaciclib dose reductions and/or the inability of study participants to reach the target dose of abemaciclib (full dose 150 mg BID) at 24 months (at completion of adjuvant abemaciclib therapy for all subjects).
Measured: Up to 24 months
Number of Participants Unable to Reach the Full Dose by 24 Months
Number of participants who have never reached the full dose of abemaciclib at 150mg BID by 24 months.
Measured: Up to 24 months
Number of Participants Who Discontinued Abemaciclib Treatment Due to Any Reason Prior to 24 Months
Number of Participants who Discontinued Abemaciclib Treatment Due to Any Reason prior to 24 Months (at completion of adjuvant abemaciclib therapy for all subjects).
Measured: Up to 24 months
Number of Participants With Abemaciclib Dose Reductions at 24 Months
Number of Participants with Abemaciclib Dose Reductions at 24 months (at completion of adjuvant abemaciclib therapy for all subjects).
Measured: Up to 24 months
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Months
Number of participants who reached the full dose of abemaciclib (150mg BID) but then had a dose reduction by 24 months
Measured: Up to 24 months
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Months
Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent diarrhea adverse event reported per subject (across any dose level received) between the start of treatment and up to 24 months. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib.
Grade 0 - no toxicity reported
Grade 1 - mild
Grade 2 - moderate
Grade 3 - severe
Grade 4 - life-threatening
Grade 5 - fatal
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Oct 2023
- Primary completion22 Jan 2025
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Erica Mayer, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Erica Mayer, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001762
- Sponsor's protocol ID
- 23-355
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2023
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06001762
- Acronym / sponsor ID
- 23-355
- Keywords
- Breast Cancer, Early-stage high-risk breast cancer, Early-stage breast cancer, High risk breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer.
The names of the study drugs involved in this study are:
- Abemaciclib (CDK4 and CDK6 inhibitor)
- Tamoxifen (Selective estrogen receptor modulator)
- Anastrozole/Letrozole (Non-steroidal aromatase inhibitors)
- Exemestane (steroidal aromatase inhibitor)
- LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
Detailed description
This research study is a prospective, single-arm, open label, phase 2 study designed to evaluate if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer.
This research study involves adjuvant abemaciclib plus endocrine (anti-hormone) therapy that works to target breast cancer. Adjuvant therapy is treatment given after surgery, chemotherapy, and/or radiation therapy.
The U.S. Food and Drug Administration (FDA) has approved abemaciclib as a treatment option for early-stage high-risk hormone receptor breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer.
The research study procedures include screening for eligibility, study treatment including laboratory evaluations and questionnaires, blood tests, tumor biopsies, and stool collections.
Participation in this research study is expected to last for at least 2 years and up to 5 years.
It is expected that about 90 people will take part in this research study.
Eli Lilly and Company is supporting this study by providing funding for the study and supplying the study drug, abemaciclib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abemaciclib | Experimental | Drug: Abemaciclib, Drug: Tamoxifen, Drug: Anastrozole, Drug: Letrozole, Drug: Exemestane, Drug: LHRH AgonistStudy procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Stage II or III node-positive HR+/HER2- breast cancer per local laboratory assessment.
- Eligible participants must be appropriate candidates for adjuvant abemaciclib, per assessment of their treating physician.
- Participants must be candidates for adjuvant endocrine therapy, which may have started before or at time of entry onto the trial. Patient may be receiving adjuvant aromatase inhibitor or tamoxifen, +/- ovarian suppression.
- Participants must have undergone definitive surgery of the primary breast tumor(s) within 16 months of study entry.
- At least 21 days must have elapsed between last dose of chemotherapy and registration. Participants who previously received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization.
Key exclusion criteria (21 listed)
- Prior treatment with any CDK4/6 inhibitor.
- Patients with node-negative breast cancer are not eligible for the trial.
- Concurrent therapy with other investigational agents.
- Diagnosis of inflammatory breast cancer (T4d).
- History of allergic reactions attributed to abemaciclib or similar chemical or biologic composition or excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibCDK4 and CDK6 inhibitor, tablet taken orally | Drug | Abemaciclib |
| TamoxifenSelective estrogen receptor modulator, taken orally per institutional standard of care | Drug | Abemaciclib |
| AnastrozoleNon-steroidal aromatase inhibitor, taken orally per institutional standard of care | Drug | Abemaciclib |
| LetrozoleNon-steroidal aromatase inhibitor, taken orally per institutional standard of care | Drug | Abemaciclib |
| ExemestaneSteroidal aromatase inhibitor, taken orally per institutional standard of care | Drug | Abemaciclib |
| LHRH AgonistLuteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care | Drug | Abemaciclib |
Primary outcome
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks)
Time frame: 3 months (12 weeks)
The composite endpoint is the number and proportion of participants with abemaciclib discontinuation for any reason and/or abemaciclib dose reductions and/or the inability of study participants to reach the target dose of abemaciclib (full dose 150 mg BID) at 3 months (12 weeks).
16 secondary outcomes
Number of Participants Unable to Reach Full Dose of Abemaciclib at 3 Months (12 Weeks)
Time frame: 3 months (12 weeks)
Number of Participants Who Discontinued Abemaciclib Treatment for Any Reason at 12 Weeks
Time frame: 3 months (12 weeks)
Number of Participants With Abemaciclib Dose Reductions at 12 Weeks
Time frame: 3 months (12 weeks)
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Weeks
Time frame: Up to 24 weeks
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Adverse Events by 24 Weeks
Time frame: Up to 24 weeks
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Weeks
Time frame: Up to 24 weeks
Number of Participants Unable to Reach the Full Dose by 24 Weeks
Time frame: Up to 24 weeks
Number of Participants Who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks
Time frame: Up to 24 weeks
Number of Participants With Abemaciclib Dose Reductions at 24 Weeks
Time frame: Up to 24 weeks
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Weeks
Time frame: Up to 24 weeks
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Months
Time frame: Up to 24 months
Number of Participants Unable to Reach the Full Dose by 24 Months
Time frame: Up to 24 months
Number of Participants Who Discontinued Abemaciclib Treatment Due to Any Reason Prior to 24 Months
Time frame: Up to 24 months
Number of Participants With Abemaciclib Dose Reductions at 24 Months
Time frame: Up to 24 months
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Months
Time frame: Up to 24 months
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Months
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Mayer, MD, MPH principal investigator
Dana-Farber Cancer Institute
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib, Tamoxifen and Anastrozole in people with Breast Cancer and Early-stage Breast Cancer, run by Dana-Farber Cancer Institute at 12 sites in United States.
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 24 inclusion and 21 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Jul 2026). 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?
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks) (time frame: 3 months (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.