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Southeast Cancer Control Consortium, Inc.

Breast Cancer

Protocol Number Study Title

CALGB 40502
A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixabepilone
Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

CALGB 40503
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

CALGB 40601
Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib or Both as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer

CALGB 40603
Randomized Phase II 2x2 Factorial Trial of the Addition of Carboplatin and/or Bevacizumab To Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer

CALGB 70301
Quality of Life, Employment and Informal Care Cost Analysis in Women Receiving Adjuvant Chemotherapy for Breast Cancer with 0-3
Positive Axillary Lymph Nodes

CALGB 70305
A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

CCCWFU 97202
A Randomized Double-Blind Placebo-Controlled Study of Oral Coenzyme Q10 to Relieve Self-Reported Cancer Treatment Related Fatigue in
Breast Cancer Patients

CTSU 25-02
Tamoxifen and Exemestane Trial (TEXT)

A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer

Ovarian function suppression + tamoxifen versus
Ovarian function suppression + exemestane

CTSU 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

CTSU MA.27
Temp clos 5/21/08
A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer

CTSU MA.32
A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

CTSU N063D ALTTO
Design 2 closed 3/31/10
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

CTSU N0733
Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 in Patients with HER2 Positive Breast Cancer Previously Treated with Trastuzumab and an Anthracycline and/or a Taxane

CTSU PACCT-1
Pre-Regis closed 8/20/10
Program for the Assessment of Clinical Cancer Tests (PACCT-1):Trial Assigning IndividuaLized Options for Treatment:The TAILORx Trial

CTSU Z1031
A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

CTSU Z1041
A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed By Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with HER-2 Positive Operable Breast Cancer

CTSU Z1071
A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis

HLMCC 0806
Phase II Placebo-Controlled Trial of Lisinopril and Coreg to Reduce
Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin)

MA.27B
The Influence of Five Years of Adjuvant Anastrozole or Exemestane
on Bone Mineral Density (Bmd) in Postmenopausal Women
with Primary Breast Cancer

NSABP B-41
A Randomized Phase III Trial of Neoadjuvant Therapy for Patients with Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered with Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response

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

NSABP B-44-I (BETH)
A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy
Plus Trastuzumab Plus Bevacizumab

NSABP B46-I
A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to
TC Alone and to TAC for Women with Node-Positive or High-Risk Node-Negative,
HER2-Negative Breast Cancer

NSABP BP-59
Bone Marrow Analysis in Early-Stage Breast Cancer

NSABP FB-6
A Phase II Clinical Trial of Four Cycles of Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Given Concurrently with Pazopanib as Neoadjuvant Therapy Followed by Postoperative Pazopanib for Women with Locally Advanced Breast Cancer

RTOG 0413
Clos to lo-risk women 12/30/06
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

RTOG 1014
A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

SWOG S0221
Phase III Trial of Continuous Schedule AC + G Vs. Every 2 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

SWOG 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

SWOG S0511
A Phase II Study of Goserelin Plus Anastrozole as First Line Treatment in Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer

SWOG S0622
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer

SWOG S0715
Randomized Placebo-Controlled Trial of Acetyl L-Carnitine for the Prevention of Taxane Induced Neuropathy

SWOG S0800
A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) With or Without Bevacizumab, Either Preceded by or Followed by Every Two Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim PEG-G) As Neoadjuvant Therapy for Inflammatory and Locally Advanced
Her-2/Neu Negative Breast Cancer
  2150 Country Club Road, Suite 200, Winston-Salem, NC 27104-4241
Phone: (336) 777-3036 Fax: (336) 777-3177 Email: scccinfo@wfubmc.edu
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