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
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 B-43
Adjuvant Therapy for Patients with HER2 Positive Ductal Carcinoma In Situ Two doses of Herceptin in conjunction with Radiation.

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

ALTTO - N063D
(Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial )
Phase III Comparing activity of lapatinib alone vs Trastuzumab alone vs lapatinib followed by Trastuzumab vs Lapatinib concomitantly with trastuzumab in adjuvant treatment of patients with ErbB2 over-expressing breast cancer - must have received adjuvant treatment with an anthracycline based therapy. Taxane allowed before or during targeted therapy - see protocol for guidelines.

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

CINJ 040804
A Phase I/II Study of Ixabepilone in Combination with the Autophagy Modulator Hydroxychloroquine for the Treatment of Patients with Metastatic Breast Cancer. Must have received 2 prior chemotherapy's (anthracycline within 6 mo in the adjuvant setting or 3 mo in the metastatic) AND Taxane-resistant (within 12 mo in the adjuvant or 4 mo in the metastatic setting)

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 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