Can older women with breast cancer skip chemo? new trial tests CDK4/6 inhibitors
NCT ID NCT07826052
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether women aged 65 and older with early-stage, lymph node-positive, ER+/HER2- breast cancer can safely skip chemotherapy. Participants receive CDK4/6 inhibitors, with or without endocrine therapy, after surgery. The trial tracks how many women remain free of invasive disease after five years and monitors side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CDK4/6 inhibitors such as abemaciclib, ribociclib, dalpiciclib, or palbociclib, with optional endocrine therapy
- What this could lead to
- If it works, older women with this type of breast cancer could avoid chemotherapy and its side effects while still controlling the disease.
- What could go wrong
- This is a single-arm Phase II trial, so it cannot prove the approach is as good as chemotherapy. The results may not apply to all older patients, and CDK4/6 inhibitors can cause side effects like low blood counts and lung inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 494 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Oct 2035
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
65 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 1. Age: Female patients aged ≥65 years. 2. Disease Status: Histologically confirmed early-stage breast cancer after surgery with ER expression ≥50% AND one of the following: 1. ≥4 positive lymph nodes 2. 1-3 positive lymph nodes plus at least one of the following high-risk features: i. High-risk multigene assay result ii. Primary tumor size \>2 cm iii. Histologic grade 3 iv. Lymphovascular invasion (LVI) positive v. Ki-67 \>20% 3. Treatment Acceptance: Willing to receive adjuvant CDK4/6 inhibitor therapy. 4. Performance Status: ECOG score 0-2. 5. Adequate Organ Function: a) Hematology (within 14 days, no transfusion): i. Hemoglobin (Hb) ≥90 g/L ii. Absolute neutrophil count (ANC) ≥1.5×10⁹/L iii. Platelets (PLT) ≥100×10⁹/L b) Biochemistry: i. Total bilirubin (TBIL) ≤1.5×ULN ii. ALT/AST ≤3×ULN iii. Serum creatinine (Cr) ≤1×ULN iv. Estimated creatinine clearance (CrCl) \>50 mL/min (Cockcroft-Gault formula) 6. Consent \& Compliance: Willing to participate, sign informed consent, and comply with follow-up. Exclusion Criteria: * Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy). 2\. Bilateral breast cancer. 3. History of other malignancies, except: Cured basal cell carcinoma of the skin; Carcinoma in situ of the cervix 4. Distant metastasis (any site). 5. Any T4 lesion (UICC 1987 TNM staging), including: Skin invasion; Fixed mass adherence; Inflammatory breast cancer 6. Concurrent participation in other clinical trials. 7. Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal), including: a) LVEF \<50% (by echocardiography) b) Major cardiovascular/cerebrovascular events within 6 months before randomization: i. Unstable angina ii. Chronic heart failure iii. Uncontrolled hypertension (\>150/90 mmHg) iv. Myocardial infarction or stroke c) Poorly controlled diabetes mellitus d) Severe hypertension 8. Known allergy to taxane-based drugs or their excipients. 9. Severe or uncontrolled infections. 10. History of psychoactive drug abuse (unable to abstain) or psychiatric disorders. 11\. Patients deemed ineligible by investigator assessment. 12. Refusal to receive adjuvant CDK4/6 inhibitor therapy.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adjuvant therapy are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Can High-Risk breast cancer patients skip an extra radiation boost?
- Radioactive probe lights up CD73 on breast tumors in PET scans
- Can time with horses help cancer patients feel better?
- Can an oral drug replace injections for advanced breast cancer?
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?