Breast Cancer Clinical Trials

Protocol Description Setting Population

NSABP B-43

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2 Positive Ductal Carcinoma In Situ Resected by Lumpectomy

DCIS (mixed DCIS and LCIS are eligible)

HER2+ as determined by central testing; all DCIS resected by lumpectomy

Genentech SystHER ML 28257

An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with HER2 Positive (HER2+) Metastatic Breast Cancer

Stage IV

Diagnosis of HER2+ MBC up to 6 months prior to enrollment

Agendia PROMIS Prospective Registry Of MammaPrint in breast cancer patients with an Intermediate recurrence Score Stage I-III Node negative, hormone receptor positive,Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30)
AstraZeneca FALCON D699BC00001 A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM)500 mg with Anastrozole IMIDEXTM) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy (FALCON) Locally Advanced or Metastatic ER &/or PR + locally advanced disease not amenable to surgery or radiotherapy or Stage 4. May have had one line of cytotoxic chemotherapy, following which they must remain unsuitable for therapy of curative intent.
PUMA-NER-1301 A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients with HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting (NALA) Metastatic Prior tx with >2 prior HER2 directed regimens for MBC; HER2+ (IHC 3+ or IHC 2+ with FISH+)

Questions

If you have any question on your eligibility for any of these trials or any general questions please feel free to contact our Clinical Research Coordinator at 773.665.9837(P), or fax at 773-665-6890.

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