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Clinical Trials
Did you know Clearview Cancer Institute has been involved in Clinical Research for over 18 years? Findings from clinical trial research have led to significant advances in cancer prevention and treatment, and Clearview offers numerous clinical trials whereby patients who volunteer for them receive innovative, state-of-the-art cancer care.
Breast Cancer
B-46 – A Phase III clinical trial comparing the combination of Taxotere and Cytoxan plus Bevacizumab (TCB) to Taxotere and Cytoxan (TC) alone and to Taxotere, Adriamycin and Cytoxan (TAC) for women with node positive or high risk node negative, HER2 negative breast cancer
Rationale:
The addition of Bevacizumab to a taxane regimen in first line metastatic breast cancer has proven to improve outcomes. Therefore, by adding Bevacizumab to a non anthracycline treatment regimen may improve outcomes without increasing toxicity. Based on past adjuvant colon studies, the addition of Bevacizumab to a non anthracycline treatment regimen showed no increase in left ventricular ejection fraction rates of patient, therefore evaluation of adding Bevacizumab to a non antracycline regimen on breast cancer should be studied further. In addition, retrospective analysis of trials comparing anthracycline based regimens to non anthracycline based regimens have demonstrated the incremental benefit of anthracyclines may largely be confined to women with HER2 positive breast cancer. Since anthracyclines are associated with an increase risk of cardiotoxicity, evaluating regimens that do not contain anthracycline is warranted.
Purpose:
To determine whether the addition of Bevacizumab to the TC regimen improves invasive free survival relative to TC alone. The trial will also determine whether the regimen of TCB improves invasive disease free survival relative to the TAC chemotherapy regimen.
Eligibility:
- Performance status – 0-1
- Must have unilateral invasive breast cancer based on histologic examination
- Must be HER2 negative breast cancer
- Mastectomy or lumpectomy accepted
- Adequate labs
- Adequate cardiac function
- Cannot have uncontrolled hypertension
- Cannot be on therapeutic doses of Coumadin or equivalent
Treatment:
Patients will be randomly assigned to one of three treatment groups:
- Group 1 – TAC - Taxotere, Adriamycin and Cytoxan
- Group 2 – TC - Taxotere and Cytoxan
- Group 3 – TCB - Taxotere and Cytoxan plus Bevacizumab followed by B alone for a total of one year.
Contact:
Kathy Cutter, RN, BSN / 256-705-4248
TITAN is a phase III study of Doxorubicin and Cyclophosphamide followed by Ixabepilone versus Doxorubicin and Cyclophosphamide followed by Paclitaxel in patients with triple negative early stage Breast Cancer
Rationale:
This nationwide trial is evaluating the role of ixabepilone in triple negative disease, a poor-prognostic subset of breast cancer patients. Ixabepilone has demonstrated many advantages in triple negative breast cancer including targeting the Beta III tubulin commonly over expressed in these tumors and a source of taxane resistance. In addition, ixabepilone is less prone to the usual mechanisms of drug resistance.
Purpose:
The primary objective is to compare the 5 year disease free survival of women with triple negative early stage breast cancer following adjuvant treatment with Doxorubicin and Cyclophosphamide followed by every 3 week Ixabepilone versus Doxorubicin and Cyclophosphamide followed by weekly Paclitaxel
Eligibility:
- Histologically confirmed invasive unilateral breast cancer
- HER2 negative confirmed by FISH or IHC
- ER and PR negative
- Node positive: >0.2mm metastasis in at least one lymph node
- Or Node negative, with primary tumor > 1.0 cm
- Less than < 84 days from having completed definitive primary breast surgery
Treatment:
Patients will be randomly assigned to one of the following treatment groups:
- Arm 1 - Doxorubicin & Cyclophosphamide every 3 weeks for 4 cycles. Followed by Ixabepilone by mouth every 3 weeks for 4 cycles (12 weeks)
- Arm 2 -Doxorubicin & Cyclophosphamide every 3 weeks for 4 cycles. Followed by Paclitaxel weekly for 12 weeks
Contact:
Jane Taylor @ 256-327-5646
FB-6 - A Phase II Clinical Trial of Four (4) Cycles of Doxorubicin and Cyclophosphamide Followed by weekly Paclitaxel given concurrently with Pazopanib as Neo Adjuvant Therapy followed by Postoperative Pazopanib for Women with Locally Advanced Breast Cancer.
Rationale:
The primary aim of the study is to determine the pathologic complete response rate in the breast and nodes following neo-adjuvant therapy with AC followed by Paclitaxel given concurrently with Pazopanib.
Eligibility:
- Diagnosis of Invasive Adenocarcinoma of the Breast
- Stage III with Primary Breast Tumor > 2cm or Inflammatory Carcinoma
- HER-2neu Negative Breast
- Adequate cardiac function by Echo or Muga
Treatment:
- Doxorubicin & Cyclophosphamide every 21 days for 4 cycles
- Weekly Paclitaxel Day 1, 8, 15 every 28 days for 4 cycles Plus Pazopanib 800mg by mouth daily
- Surgery
- Pazopanib 800mg by mouth daily for 6 months
Contact:
Jane Taylor @ 256-327-5646
SYN-275-0301 - A Phase 2, Randomized, Double blind, Multicenter study of Exemestane with and without SNDX-275 in Postmenopausal Women with Locally Recurrent or Metastatic Estrogen Receptor Positive Breast Cancer, Progressing on Treatment with a Non-Steroidal Aromatase Inhibitor
Purpose:
To compare the efficacy of Exemestane alone with Exemestane plus Entinostat (SNDX-275) as determined by the duration of progression free survival from the date of randomization
Eligibility:
- Postmenopausal women
- Histologically or cytologically confirmed Estrogen Receptor positive +
- Relapsed or progressed on prior Aromatase Inhibitor (AI) treatment
- Evidence of metastatic disease or at least 1 measurable lesion
- ECOG 0-1
- Palliative radiation therapy must have 2 week wash out period prior to enrollment
- Patients may have had one prior chemotherapy as first line therapy for metastatic disease prior to AI
Treatment:
Patients will be randomized to one of the following treatments:
- ARM A – Exemestane 25mg daily plus Entinostat 5mg PO every week
- ARM B – Exemestane 25mg daily plus Placebo PO every week
Contact:
Jane Taylor @ 256-327-5646
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
Rationale:
The HER2/neu proto-oncogene is over-expressed in some breast and ovarian cancers which is associated with increased rate of metastasis, decreased time to recurrence and decreased survival. Currently patients that overexpress HER2/neu are treated with Trastuzumab alone, however, not all patients respond to this treatment. This study will compare the current treatment with chemotherapy plus Trastuzumab +/- Bevacizumab based on the strong biologic rationale that casually links HER2 and VEGF signaling pathways.
Purpose:
Determine whether chemotherapy + Trastuzumab + Bevacizumab improves invasive disease free survival relative to chemotherapy + Trastuzumab
Eligibility:
- Must have invasive adenocarcinoma of the breast with no metastatic disease
- Central HER2-positive testing
- Total mastectomy or lumpectomy
Treatment:
Doxetaxel + Carboplatin + Trastuzumab (q3w X 6 cycles), then Trastuzumab (q3w to complete 1 year of therapy) +/- Bevacizumab
Contact:
Kathy Cutter, RN, BSN 256-705-4248
Current Clinical Trials:
If you are interested in more information on clinical trials at Clearview, please feel free to contact us (256) 705-4224. More information regarding clinical trials can be found at: www.ClinicalTrials.gov