Phase 2 Breast Cancer Trial, Recruiting NCT01042379 Sponsor: QuantumLeap Healthcare Collaborative Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT01042379
Recruiting Phase 2

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:

  • People who have been diagnosed with invasive breast cancer confirmed by laboratory testing of tissue samples
  • People who have a measurable area of cancer in the breast (the longest measurement must be at least 2.5 cm) after an initial diagnostic biopsy
  • People who have not previously had chemotherapy or radiation therapy to the affected breast for this cancer (prior bone-strengthening bisphosphonate therapy is allowed)
  • People aged 18 years or older
  • People whose general health and ability to carry out daily activities meets a level rated 0 or 1 on a standard medical scale (confirm with trial site)
  • People who are willing to have a core biopsy taken from the breast tumour to measure certain biological markers before treatment begins
  • People who are not pregnant and not breastfeeding
  • People who do not have any metallic implants in their body that are not compatible with an MRI machine
  • People who are able to understand and are willing to sign the required consent forms for this trial
  • People whose cancer is classified as Stage II or III, or a specific advanced stage affecting only the lymph nodes above the collarbone, or inflammatory breast cancer meeting the trial's staging criteria (confirm with trial site)
  • People whose tumour has any level of hormone receptor status (ER/PgR) and any HER-2 status, as long as the tumour meets the specific testing profile described in the trial protocol (confirm with trial site)
  • People whose blood and organ function results fall within the required ranges, including adequate white blood cell counts, platelet levels, liver function, and kidney function (confirm with trial site)
  • People who do not have severe or uncontrolled heart disease, and whose heart pumping function is at least 50% as measured by imaging
  • People who have no signs of cancer that has spread to distant parts of the body, confirmed by chest X-ray, bone scan, and blood tests
  • People whose tumour meets one of the specific testing profiles using a tool called MammaPrint, combined with hormone receptor and HER2 results (confirm with trial site)

Who may not be able to join:

  • People who have taken part in another experimental drug trial within the 30 days before starting this study
  • People who have had a serious allergic reaction to medicines that are chemically or biologically similar to the treatments used in this trial
  • People who have other serious, uncontrolled illnesses such as an active infection, heart failure, unstable chest pain, irregular heart rhythms, or mental health or personal circumstances that would make it difficult to follow the trial's requirements

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 19 July 2026
Phase 2: approximately ~30% 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.

Contact this trial

Principal Investigator: Laura Esserman, MD, MBA, University of California, San Francisco

Phone: (855) 866-0505

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

Status
Recruiting
Phase
Phase 2
Sponsor
QuantumLeap Healthcare Collaborative
Registry
ClinicalTrials.gov
Start date
1 March 2010
Est. completion
1 December 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.

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: 19 July 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