Phase 3 Breast Cancer Trial, Recruiting NCT01785420 Sponsor: Dr Rajendra A. Badwe Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT01785420
Recruiting Phase 3

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:

  • Women aged 18 years or older.
  • People with a confirmed diagnosis of breast cancer (confirmed through tissue or cell testing), at a stage that is either early or locally advanced but has not spread to distant parts of the body, and where the tumour is considered removable by surgery if applicable.
  • People whose breast cancer tests positive for a protein called HER2, confirmed by specific laboratory tests (FISH, CISH, or IHC testing) showing the cancer has too many copies of the HER2 gene or too much HER2 protein.
  • People whose heart pumping function falls within the normal range, as measured by a heart scan (MUGA or echocardiogram).
  • People whose blood test results at screening meet specific levels for white blood cells, platelets, red blood cells, kidney function, and liver function (confirm specific values with trial site).

Who may not be able to join:

  • People who have cancer in both breasts at the same time.
  • People with serious heart conditions that are not well controlled, including heart muscle disease, significant heart failure, unstable chest pain, or a heart attack in the past 12 months.
  • People with high blood pressure that is not well controlled (blood pressure readings above certain levels at the time of screening).
  • People with a personal or family history of certain inherited heart rhythm conditions, or who currently have an abnormal heart rhythm measurement on an ECG.
  • People with a long-term bowel condition where ongoing diarrhoea is a major symptom, such as Crohn's disease or a significant absorption problem.
  • People who are pregnant or currently breastfeeding.

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
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Dr Rajendra A. Badwe
Registry
ClinicalTrials.gov
Start date
1 May 2013
Est. completion
1 April 2025

Where this trial is recruiting

🇮🇳 India

Primary endpoints

Disease Free Survival

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

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