Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,900 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for women aged 18-80 with specific types of breast cancer and 1-3 positive lymph nodes. Participants will receive a treatment called abemaciclib for three years and will help researchers understand if chemotherapy can be avoided.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18-80 years old.
I have localized invasive breast cancer with 1-3 positive lymph nodes.
I have been tested and my cancer is ER+/HER2-.
My tumor has estrogen receptor levels of at least 50%.
I have a performance status of 0 or 1.
I have good blood cell and organ function.
I have signed consent to participate.
You may not be able to join if
I have received any neoadjuvant therapy before my surgery.
I have bilateral breast cancer.
I have a history of other cancers, except for certain types.
I have metastatic breast cancer.
I have a serious heart or organ condition.
I am pregnant or breastfeeding, or cannot use effective contraception.
I have a severe or uncontrolled infection.
I am currently participating in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* women aged 18-80 years old;
* Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, T1-T2,and is ER+/HER2- confirmed by histopathology after early breast cancer surgery#HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a ne…
Inclusion Criteria:
* women aged 18-80 years old;
* Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, T1-T2,and is ER+/HER2- confirmed by histopathology after early breast cancer surgery#HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) .
* ER≥50%
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤
1×ULN#and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula).
* Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Exclusion Criteria:
* Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy#;
* Has bilateral breast cancer;
* Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
* Has metastatic (Stage 4) breast cancer;
* Has any ≥T3 lesion
* Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
* Patients participating in other clinical trials at the same time;
* Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
* Has severe or uncontrolled infection;
* the researchers judged patients to be unsuitable for the study.
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