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New treatment option for Breast Cancer
Official title Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
ClinicalTrials.gov ID: NCT06341621
What this study is testing
What is 3-year abemaciclib without chemo?
3-year abemaciclib without chemo is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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;
See the full eligibility 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...
- 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 \...
- 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.
- 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) \ 150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood...
- Has severe or uncontrolled infection;
- the researchers judged patients to be unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.