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Contact Information

General Phone Number
888-844-8447
216-844-8447
Mailing Address
11100 Euclid Avenue
Cleveland, OH 44106
Clinical Trials

Trial Name:

S 0230
Intro: S 0230: Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Standard Adjuvant Chemotherapy in Early Stage, Hormone Receptor Negative Breast Cancer
Condition:
Description: This research study is being conducted for premenopausal women with early-stage hormone-receptor negative breast cancer. It will compare the rate of premature ovarian failure following standard adjuvant (assisting in the cure of disease) chemotherapy with or without the addition of ovarian suppression with a drug called a LHRH analog (luteinizing hormone-releasing hormone) during chemotherapy. Also, it will compare the rates of ovarian dysfunction following this treatment and evaluate ovarian reserves. The study will also describe pregnancy and fertility in the two groups after treatment and during the five-year follow-up period.
Criteria:
  1. Have a histologically confirmed diagnosis of operable Stage I, II, or IIA invasive breast cancer. Patients who have completed surgery must have pathologic Stage I, II, or IIA disease. 
  2. Be premenopausal 
  3. Have tumors that are both estrogen receptor negative and progesterone receptor negative
  4. Be 18 years of age or greater and under age 50 
  5. Accept that planned treatment may include 3 to 8 months of cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen, that chemotherapy will be administered in the pre-operative setting but not in the post-operative setting, and must be registered within 84 days after the final surgical procedure required to treat the primary tumor or axilla
  6. Performance status 0-2
  7. Be able to give written informed consent.
Contact: For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422

Participant Confidentiality:

All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

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