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 |