Phase 3 Breast Cancer Trial, Completed NCT00082433 Sponsor: R-Pharm Condition: Breast Cancer
Back to Breast Cancer

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 1,221 people with breast cancer — 609 in a group receiving a combination of two medicines (ixabepilone plus capecitabine) and 612 in a group receiving capecitabine alone. The trial was primarily looking at how long it took for the cancer to start growing again or for participants to pass away (called "progression-free survival"), as well as a number of other measures including how many participants' tumours shrank, how long that shrinkage lasted, and how participants reported feeling during treatment. The reported data shows that, on average, the time before the cancer progressed was 6.24 months in the combination group and 4.40 months in the capecitabine-only group. When it came to tumour shrinkage, 43.3% of participants in the combination group had their tumours shrink to a meaningful degree, compared with 28.8% in the capecitabine-only group. Among those whose tumours did shrink, the reported data shows the shrinkage lasted a median of 6.1 months in the combination group and 6.3 months in the capecitabine-only group. The time it took for tumours to first start shrinking was reported as 6.6 weeks in both groups. Regarding how participants reported their symptoms on a quality-of-life questionnaire (where higher scores mean fewer symptoms), the reported data shows scores generally declined over time in the combination group and remained more stable or improved slightly in the capecitabine-only group, though the full breakdown of those figures was not clearly separable from the submitted 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, Completed

NCT00082433
Completed Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • You must have previously been treated with chemotherapy drugs from two specific groups: one called an anthracycline (such as doxorubicin or epirubicin) and one called a taxane (such as paclitaxel or docetaxel).
  • You must have had no more than two previous chemotherapy treatment courses in total.
  • If you have not yet received treatment for cancer that has spread to other parts of the body, your cancer must have come back within one year of your earlier treatment.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You may not be eligible if your cancer has ever spread to the brain or to the membranes surrounding the brain or spinal cord.
  • You may not be eligible if you currently have moderate or severe nerve damage (such as numbness, tingling, or pain in your hands or feet) at the time of joining the trial (confirm with trial site).
  • You may not be eligible if you have previously been treated with a drug from a group called epothilones, or with a drug called capecitabine (also known as Xeloda).

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
R-Pharm
Registry
ClinicalTrials.gov
Start date
1 November 2003
Est. completion
1 March 2008

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇹 Portugal 🇷🇺 Russia 🇸🇬 Singapore 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 11 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Overall Survival (OS)

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov