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Clinical Trials: Breast Cancer

Treatment Trials

Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Scott Kurtzman

Title: NSABP B38: A Phase 3 Adjuvant Trial Comparing 3 Chemotherapy Regimens in women w/Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose Dense (DD) Doxorubicin/Cyclophosphamide followed by DD Paclitaxel (DD AC-P); DD AC Followed by DD Paclitaxel plus Gemcitabine (DD AC-PG)

Description: The study is being conducted to see if the addition of a new drug, gemcitabine to a dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel is better at treating node positive breast cancer than standard docetaxel/doxorubicin/cyclophosphamide and double-dense doxorubin/cyclophosphamide followed by paclitaxel. The study will also look at the toxicities associated with these regimens.

Length/Duration: Treatment phase 4 to 5 months, follow-up phase, 5 years

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 05-118

Sponsor: National Surgical Breast and Bowl Project (NSABP)


Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Scott Kurtzman

Title: NSABP B39: A Randomized Phase 3 of Conventional Whole Breast Irradiation vs. Partial Breast Irradiation for Women with Stage 0, I, or II Breast Cancer

Description: Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. The purpose of this study is to see if partial breast irradiation (PBI) is as good as or better than whole breast irradiation (WBI) in keeping cancer from coming back in the breast.

Length/Duration: 5 years

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 05-224

Sponsor: National Surgical Breast and Bowl Project (NSABP)


Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Scott Kurtzman

Title: NSABP B36. A clinical Trial of Adjuvant Therapy Comparing 6 cycles of 5-FU, Epirubicin and Cyclophosphamide (FEC) to 4 Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node Negative Breast Cancer

Description: The study is being conducted to see if 6 cycles of FEC-100 (5-Fu, epirubicin, and cyclophosphamide) is better at treating node negative breast cancer than the standard 4 cycles of AC (doxirubicin and cyclophosphamide).

Length/Duration: 4 to 5 months treatment phase, follow-up phase 5 years

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 04-289

Sponsor: National Surgical Breast and Bowl Project (NSABP)

Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Scott Kurtzman

Title: NSABP B37: A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer

Description: The purpose of this study is to determine if the addition of chemotherapy to the standard treatment of surgery and radiation is better in treating locally relapsed breast cancer as compared to the standard treatment of surgery plus radiation. Recent evidence suggests that there may be a role for the addition of chemotherapy to possibly increase the overall survival rate in addition to the standard treatment.

Length/Duration: Treatment up to 8 months, follow-up 10 years

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 05-256

Sponsor: National Surgical Breast and Bowl Project (NSABP)


Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Scott Kurtzman

Title: NSABP B35: A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma In Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy

Description: The purpose of this study is to evaluate the effectiveness of anastrozole in stopping a recurrence of breast cancer in postmenopausal women that were initially diagnosed with DCIS that was treated with lumpectomy and breast radiation.

Length/Duration: 5 years

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 03-180

Sponsor: National Surgical Breast and Bowl Project (NSABP)

Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Susan Tannenbaum

Title: A phase III trial evaluating the role of Exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine responsive breast cancer (Tamoxifen and Exemestane Trial (TEXT) study)

Description: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women that have had surgery for ER and/or PgR breast cancer. Women may receive (at their doctor's recommendation) chemotherapy at the same time they are receiving study medication.

Length/Duration: Depending on how well they respond to therapy, subjects will receive drug for up to five years.

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 05-211

Sponsor: International Breast Cancer Study Group (IBCSG-25-02)


Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Susan Tannenbaum

Title: An Open-Label, Single Arm Study of Capecitabine (Xeloda) in Combination w/Bevacizumab (Avastin) as First-Line Treatment for HER2-Negative Metastatic Breast Cancer, followed by Chemotherapy in Combination with Bevacizumab at Time of Progression

Description: This study is for patients with Her2-neg breast cancer that has recurred (local or metastatic) or for patients that receive an initial diagnosis of Her2-neg metastatic breast cancer. The primary objective of this study is to determine if treating patients with Capecitabine and Bevacizumab increases survival.

Length/Duration: Variable, depends on response to therapy

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 05-254

Sponsor: Roche Laboratories, Inc.

Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Susan Tannenbaum

Title: An open-label study of capecitabine and docetaxel as neoadjuvant treatment for patients with recently diagnosed HER2-nue negative breast cancer plus trastuzumab for HER2-neu positive breast cancer

Description: To determine if treating the tumor with a combination of either 1) capecitabine (Xeloda®) and docetaxel (Taxotere®) for HER2-neu negative tumors or 2) capecitabine (Xeloda®), docetaxel (Taxotere®) and trastuzumab (Herceptin®) for HER2-neu positive tumors prior to surgery cause the tumor to completely disappear at or before the time of surgery.

Length/Duration: The total length of time will depend on how well you tolerate the medication and the status of your disease. The maximum time you will participate in this study is three years.

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 06-086

Sponsor: Roche Laboratories, Inc.

Prevention Trials

Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Carolyn Runowicz

Title: A phase III randomized study of exemestane vs. placebo in postmenopausal women at increased risk of developing breast cancer

Description: In this trial, a sample of women who are at high-risk for breast cancer randomly will be placed into one of two groups; the group that will receive exemestane or the group that will receive the placebo (sugar pill). Women who participate in this study will need to take one pill a day for the next five years.  Neither the participant nor the doctor/staff will know to which group the individual has been randomly placed. The investigators want to learn if exemestane is effective in preventing breast cancer in women that are at an increased risk of developing the disease.

Length/Duration: 5 years

Compensation: None

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 06-163

Sponsor: National Cancer Institute of Canada

Screening Trials

Therapeutic Area: Breast Cancer

Principal Investigator: Dr. Scott Kurtzman

Title: Serial Evaluation of Ductal Epithelium (SEDE) and Breast Health Outcomes in Women at High Risk for Breast Cancer

Description: In this trial, a sample of women who are at high-risk for breast cancer and who have no evidence of breast malignancy, will be followed over an approximate five-year period. Subjects will undergo a ductal lavage procedure on a serial basis and overall breast health will be recorded based on physical exam and mammograms.

Length/Duration: 5 years

Compensation: Maximum of $100.00

Location: Neag Comprehensive Cancer Center at the University of Connecticut Health Center

For more information, patient benefits, and to learn if you qualify: please call 860-679-3066 or send an email to dnoel@uchc.edu

IRB #: 05-005

Sponsor: Cytyc Corporation

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