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Active Research Studies for PRIMARY BREAST CANCER
Neo-Adjuvant
NSABP B-40
A Randomized Phase III Trial of Neoadjuvant Therapy in Patients withPalpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR)
of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or Without Bevacizumab and Correlative Science Studies
Attempting to Identify Predictors of High Likelihood for (pCR) with Each of the Regimens
NSABP B-41
A Randomized Phase III Trial of Neoadjuvant Therapy for Patients with Palpapable & Operable Her2 Positive Breast Cancer
Comparing the combination of Trastuzumab Plus Lapatinib vs Trastuzumab
vs Lapatinib administered with weekly Paclitaxel following AC
Adjuvant
ECOG E5103
A Double –Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed
by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node
Positive and High Risk Lymph Node Negative Breast Cancer.
NSABP B-42
A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an
AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer
NSABP B44 – BETH (Adjuvant Therapy for Patients with Her-2 positive, node positive or High Risk
Node Negative Breast)
TCH®H q 3 wks x 6 ®H X 1yr +/- Bevacizumab x 1 yr
NSABP FB-5
A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide
Followed by Docetaxes Plus Trastuzumab and Bevacizumab Given
as Neoadjuvant Therapy for HER2-Positive Locally Advanced
Breast Cancer or Given as Adjuvant for HER2-Positive Pathologic
Stage III Breast Cancer
IBCSG 24-02
A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast
Cancer Tamoxifen versus Ovarian function suppression + tamoxifen versus Ovarian
function suppression + exemestane
ECOG PACCT-1
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Taylor X Trial Assigning Individualized Options for Treatment The TAILORx Trial Oncotype Dx Assay for ER and/or PR-Positive, Negative nodes,
Tumor size 1.1-5.0 cm (or 5mm-1.0cm plus unfavorable
histological features), Her2/neu negative.
Oncotype Dx Assay test must be done
Advanced Breast Cancer
CINJOG 040702 (triple negative untreated Metastatic breast)
Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
CINJOG 040706 ( Phase I & II 1st line post menopausal Hormone receptive positive, locally advanced or Metastatic Breast)
Letrozole(Femara) & Sorafenib (Nexavar taken orally daily. (Phase I part of the trial will be done in NB
to determine the dosing, after that we can accrue.)
CINJ 040504
A Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone In
Patients with Previously Treated Locally Advanced or Metastatic Breast Cancer
CINJ 040608 (NJ 1106)
Phase II Trial of Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in Patients
with HER2-Overexpressing Advanced Metastatic Breast Cancer

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