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 (NCT00925548) enrolled a total of 16 participants. Eleven people were assigned to receive tecemotide (also called L-BLP25) together with hormonal therapy and a drug called cyclophosphamide, while five people received a placebo (an inactive treatment) together with hormonal therapy and a saltwater solution. The trial was designed to measure how long participants went without their disease getting worse (called "progression-free survival"), as well as a number of other outcomes including how long participants lived overall, whether tumours shrank, how long any shrinkage lasted, and whether participants experienced at least some stabilisation of their disease. The reported data shows that, of the 11 participants in the active treatment group, only 1 completed the study, while 10 did not complete it. In the placebo group, none of the 5 participants completed the study. Despite the trial being set up to collect results for all of these outcomes, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — not for the primary outcome (progression-free survival) or for any of the secondary outcomes (overall survival, tumour response, duration of response, clinical benefit, or time to progression). In other words, the actual figures for what happened to participants across all these measures were not reported in the data available on ClinicalTrials.gov. Because no outcome numbers were submitted, it is not possible to describe what the measurements showed for either group. The very small number of participants and the high proportion who did not finish the study may have contributed to this situation, but the reasons were not stated in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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, Terminated
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 are a woman who has gone through menopause, as defined by the trial's specific guidelines
- Your breast cancer has been confirmed by a lab test and is driven by estrogen and/or progesterone (hormone receptor-positive)
- A blood test shows you carry at least one of five specific genetic markers related to your immune system (called HLA-A2, -A3, -A11, -B7, or -B35)
- Your breast cancer has spread, come back, or cannot be removed by surgery, and you have at least one affected area that is not in a bone
- Your cancer can be measured on scans using a standard system called RECIST, and surgery is not an option
- You are generally well enough to carry out normal daily activities with little or no limitation (confirmed by a standard health scale called ECOG, scores 0 or 1)
- Your blood counts, liver, and kidney are working well enough, based on tests done within two weeks before starting treatment
- Other criteria set out in the trial documents may also apply (confirm with trial site)
Who may not be able to join:
- Your cancer got worse during or within 4 years of starting hormone therapy given after early-stage breast cancer treatment
- Your breast cancer tests positive for a protein called HER2, as defined by the trial (confirm with trial site)
- You have an autoimmune disease that the doctor feels could put you at risk in this study (though well-controlled Type 1 diabetes may be an exception)
- You have a condition that weakens your immune system, whether inherited or developed
- You have had another type of cancer in the past or currently, unless it was a non-serious skin cancer, a very early cervical cancer, or another cancer that was fully treated with no signs of return for at least five years
- You have an active Hepatitis B or C infection, HIV, or another infection that could weaken your immune response or increase the risk of serious side effects
- You received certain immune-boosting treatments, chemotherapy, or some antibody-based therapies within the 4 weeks before joining the trial (note: antibodies used only for scanning/imaging are allowed)
- You have already received non-hormonal treatments such as chemotherapy or immunotherapy for your advanced or spread breast cancer (brief hormonal therapy of up to 4 weeks before joining may be allowed — confirm with trial site)
- The only area of your cancer that can be used to measure treatment response has already been treated with radiation
- You have cancer that has spread to the brain, or you have a brain or nervous system condition confirmed by a scan
- You have a mental or physical condition that would make it difficult to understand the study, report side effects, or follow the trial's requirements
- You have a serious heart condition, such as severe heart failure, uncontrolled chest pain, uncontrolled irregular heartbeat, uncontrolled high blood pressure, or a heart attack in the past six months
- You have had your spleen removed
- You need to take other treatments not allowed by this trial at the same time, such as chemotherapy, radiation (except for pain relief to bone areas), immune-suppressing drugs, or herbal/plant-based cancer treatments
- You have taken part in another clinical trial within 30 days before joining
- You have a known allergy to the study drugs
- You have a known problem with alcohol or drug misuse
- You do not have the legal ability to make your own decisions about participating
- You have signs of, or a family history of, a rare and serious brain condition called transmissible spongiform encephalopathy (confirm with trial site)
- You may be in a situation where you feel pressured to join, such as being in a care home, detained, homeless, or in an emergency situation, as the trial aims to protect people who might feel they cannot freely choose (confirm with trial site)
- The trial doctor believes there is any other reason you should not participate
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression-Free Survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.