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Breast Cancer Clinical Trials: Does Your Patient Qualify

Patients at the Harold C. Simmons Cancer Center, the only NCI-designated center in North Texas, have access to treatment options that would otherwise be unavailable to them in the region. Physicians and researchers at UT Southwestern participate in and, in many cases, serve as principal investigators to numerous clinical trials in cancer and other diseases. Below is a small sampling of breast cancer clinical trials at UT Southwestern that are currently open to appropriate patients.

CLINICAL TRIAL

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and HER2-Negative Breast Cancer according to Recurrence Score (RS)

Summary

Patients with hormone receptor-positive breast cancer that has spread to their lymph nodes usually get both chemotherapy and hormonal therapy after surgery. But for some of these patients with low to intermediate “recurrence scores” on the Oncotype DX test, chemotherapy may offer little or no benefit; hormonal therapy alone may be enough. This trial will measure how much, if any, benefit these patients get from chemotherapy, and it will try to determine where the cutoff score is between patients who benefit from che­motherapy and patients who do just as well with hormonal therapy alone.

Patient Eligibility

A patient may be eligible for this trial if:

  • She is a woman with early breast cancer and has had or will have surgery,
  • „Her cancer is hormone-receptor positive,
  • „Her cancer is HER2-negative,
  • „Her cancer has been found in 1–3 of her lymph nodes, and
  • „She has not yet begun chemotherapy or hormonal therapy for her cancer.

CLINICAL TRIAL

A Randomized Multicenter, Double-blind, Placebo-controlled Com­parison of Chemotherapy plus Trastuzumab plus Placebo Versus Chemotherapy plus Trastuzumab plus Pertuzumab as Adjuvant Therapy in Participants with Operable HER2-positive Primary Breast Cancer

Summary

This trial will compare invasive disease-free survival (IDFS) in patients with HER2-positive breast cancer randomized to chemotherapy plus one year of trastuzumab plus placebo or chemotherapy plus one year of trastu­zumab plus pertuzumab. The participant will receive chemotherapy for 18-21 weeks through a vein (IV).

Patient Eligibility

A patient may be eligible for this trial if:

  • She is 18 years or older with nonmeta­static invasive breast carcinoma that is HER2-positive,
  • „She is not pregnant, and
  • „She has baseline LVEF of > 55%.

Patient enrollment beginning in late May

CLINICAL TRIAL

Efficacy and Safety Study of NeuVax™ Vaccine to Prevent Breast Cancer Recurrence

Summary

This trial assesses the efficacy and safety of NeuVax, a peptide (E75) vaccine adminis­tered with adjuvant Leukine® (sargramostim, GM-CSF), and will evaluate and compare the disease-free survival (DFS) in the vaccinated patients and control patients. The active por­tion of the study will last three years. The follow-up will last from five to 10 years.

Patient Eligibility

A patient may be eligible for this trial if:

  • She has an early stage Node-Positive (NP) breast cancer, and
  • „Her tumor expresses low or intermediate levels of the HER2 protein.

Patient enrollment beginning in early May

CLINICAL TRIAL

An Open-Label, Multi­center, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramu­cirumab (IMC-1121B) Drug Product or IMC-18F1 in Combination With Capecitabine or Capecitabine Monotherapy, in Unresect­able, Locally Advanced, or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy

Summary

The primary objective of this trial is to evaluate the progression-free survival (PFS) in patients with anthracycline- and taxane-pretreated unresectable, locally advanced, or metastatic breast cancer when treated with the mono­clonal antibody ramucirumab drug product in combination with capecitabine or with capecitabine monotherapy.

Patient Eligibility

A patient may be eligible for this trial if:

  • He or she is 18 years of age with his­tologically or cytologically confirmed anthracycline- and taxane-pretreated unresectable, locally advanced, or meta­static breast cancer.