Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,086 people with breast cancer — 542 in a group that received no additional chemotherapy maintenance (called "No-CM") and 544 in a group that received chemotherapy maintenance (called "CM-Maintenance"). The trial was measuring how participants fared over five years across several milestones, including whether their cancer returned, whether they developed a new cancer, and whether they were still alive. It is worth noting that 230 people in the CM-Maintenance group did not complete the study, compared to only 3 in the No-CM group. The reported data shows that the primary measure — the estimated percentage of participants who were alive and free of disease at five years — was 74.7% in the No-CM group and 78.1% in the CM-Maintenance group. For overall survival (the percentage still alive at five years regardless of disease status), the reported figures were 85.0% for No-CM and 85% for CM-Maintenance. The reported data also shows that for the "distant recurrence-free interval" (meaning cancer had not spread to other parts of the body), the five-year estimates were 83.5% for No-CM and 85.5% for CM-Maintenance. Finally, for the "breast cancer-free interval" (meaning no breast cancer had returned or appeared in the other breast), the figures were 77.3% for No-CM and 81.0% for CM-Maintenance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 27325862) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Breast Cancer Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with stage I, II, or III breast cancer, confirmed by a tissue sample (biopsy)
- Your cancer is contained within the breast and nearby lymph nodes, with no spread to other parts of the body
- You have had either a full breast removal (mastectomy) or a breast-conserving surgery (such as a lumpectomy), with clear margins (no cancer cells at the edges of what was removed)
- Radiation therapy is planned as part of your treatment
- You have started or are due to start an approved chemotherapy course within 8 weeks of your surgery
- At least 6 lymph nodes from under your arm have been checked, or a sentinel node biopsy came back negative (if a sentinel node biopsy was positive, you must have also had a full underarm lymph node removal)
- Your cancer has been tested and your HER2 status is known
- Your cancer has tested negative for both estrogen and progesterone receptors (less than 10% of tumor cells reacting to these hormones)
- Your blood counts are at acceptable levels: white blood cell count above 3,000, and platelets above 100,000
- Your liver function tests are within acceptable ranges (bilirubin below 2.0, and certain liver enzymes within normal limits)
- Your kidney function is within an acceptable range (creatinine below 1.2)
- You are either premenopausal (had a period within the last 6 months, or are under 50) or postmenopausal (no period for more than 12 months, or age 50 and over, or have had both ovaries removed)
Who may not be able to join:
- You have cancer that has spread to other parts of the body (distant metastases), or have unexplained bone pain or test results that suggest possible spread that cannot be ruled out
- You have cancer in both breasts (except for non-invasive in situ cancer), or an unexamined suspicious area in the other breast
- Your breast cancer involves significant skin involvement, open sores on the skin, or is classified as inflammatory breast cancer
- You are currently pregnant, have been pregnant or breastfeeding in the past 6 months
- You are able to become pregnant but are not using effective barrier contraception
- You have had previous chemotherapy or hormone therapy (such as tamoxifen or raloxifene) for breast cancer
- You have had previous radiation therapy for breast cancer (other than the planned treatment for this cancer)
- You have a history of another cancer, except for certain skin cancers, cervical in situ cancer, or non-invasive breast cancer in either breast
- You have a psychiatric illness or addiction that would make it difficult to take part in the study
- You have a serious non-cancer illness that would prevent you from participating safely (confirm with trial site)
- You have previously taken any preventative therapy for breast cancer
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Marco Colleoni, MD, European Institute of Oncology
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Disease-free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.