IOWA ONCOLOGY RESEARCH ASSOCIATION
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Breast Cancer Research Studies

ADJUVANT / NODE NEGATIVE
C40101    Cyclophosphamide and Doxorubicin (CA X 4 Cycles)) Versus Paclitaxel (4 cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A 2X2 Factorial Phase III Randomized Study

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

PACCT-1    Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial

S0221   Phase III Trial of Continuous Schedule AC + G Versus Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node Positive or High-Risk Node Negative Breast Cancer

ADJUVANT / NODE POSITIVE
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

S0221   Phase III Trial of Continuous Schedule AC + G Versus Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node Positive or High-Risk Node Negative Breast Cancer

WHOLE Vs. PARTIAL BREAST IRRADIATION
B-39   A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

ER / PgR POSITIVE
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

C40503   Endocrine Therapy in Combination with anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab for Women with Hormone Receptor-Positive Advanced Breast Cancer

HER2+
N063D   ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study: A Randomized, Multi-Center, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2 / ErbB2 Positive Primary Breast Cancer

METASTATIC / RECURRENT
E1104   Phase I/II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination with Trastuzumab (Herceptin) in Patients with Advanced Metastatic and/or Local Chest Wall Recurrent Her-2 Amplified Breast Cancer (temporarily suspended)

E1105   A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-Expressing Metastatic Breast Cancer

N0539   Phase II Trial of Fulvestrant and Bevacizumab in Patients with Metastatic Breast Cancer Previously Treated with an Aromatase Inhibitor (temporarily suspended)

S0500   A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

OVARIAN FUNCTION SUPPRESSION (SOFT)
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

ADVANCED
C40302   Endocrine Therapy with or without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatinib (GW572016) for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer

CANCER CONTROL
N063I   Changes in Breast Density and Plasma Hormone Levels After One Year of Aromatase Inhibitor Therapy

N04CA   Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double-Blind, Placebo-Controlled Study