Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
This study has been completed.
Information provided by (Responsible Party):
Elisavet Paplomata, Emory University
First received: July 15, 2009
Last updated: February 24, 2017
Last verified: February 2017
The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
||Randomized Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Greater Than 10 (≥ 11) and Less Than 25 (≤ 24)
Primary Outcome Measures:
- Pathologic Complete Response [ Time Frame: At time of definitive surgery ]
Patients must have measurable disease by clinical examination.
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.
If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.
Secondary Outcome Measures:
- Response Rate by Imaging [ Time Frame: Every 2 months up to 3 years ]
Arm A and recurrence score ≤10: Patients will have radiologic assessment of response to exemestane by clinical examination every 4 weeks and by radiologic assessment every 2 months. Once maximal response has been achieved (stable disease for 2 months after at least 4 months of treatment by radiologic assessment) or when 12 months of therapy has been given patients will proceed to surgery.
Arm B: Patients will be assessed for surgery after 6 cycles of docetaxel and cytoxan (TC) (18 weeks).
On arm A and recurrence score ≤10 patients will be reassessed for surgery once maximal radiologic response is achieved.
On arm B, patients will be reassessed for surgery after 6 cycles of TC (18 weeks).
Radiographic images were analyzed by a breast radiologist who looked at preoperative and postoperative breast mass imaging. If mass was smaller/less extensive, it was considered improved.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2015 (Final data collection date for primary outcome measure)
Experimental: A: Exemestane
ARM A: Patients will be treated with exemestane.
25 mg daily by mouth for 6 to 12 months.
Other Name: Aromasin
Active Comparator: B: Docetaxel and Cytoxan
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Other Name: Taxotere
Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Other Name: Cyclophosphamide
The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy or hormonal therapy before surgery, we will be able to determine if the treatment you receive is effective in treating your cancer. Prior to entering this study, a special test, called the Oncotype DX assay, will be performed on a small amount of your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to determine the likelihood that your cancer will benefit from and shrink with chemotherapy and hormonal therapy. You will only be eligible to enter this study if the recurrence score of your cancer determined using the Oncotype DX assay is less than or equal to 24. Patients with hormone receptor-positive breast cancers with recurrence scores less than or equal to 24 have been previously demonstrated to obtain a larger benefit from hormonal therapy, compared to chemotherapy, when these agents are given after surgery. The ability of hormonal agents and chemotherapy to shrink cancers prior to surgery has not been specifically examined in hormone receptor-positive cancers with recurrence scores less than or equal to 24.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.
- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
- Pregnant or lactating women are not eligible. Women of childbearing potential must have a negative serum pregnancy test completed within 7 days of study entry, and use an appropriate form of birth control throughout the trial period.
- Medical, psychological or surgical condition which the investigator feels might compromise study participation.
- Patients with history within the last 5 years of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.
- Evidence of peripheral or sensory neuropathy.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are excluded from participation.
- Serious, uncontrolled, concurrent infection(s).
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months prior to study entry.
- Major surgery within 28 days of study entry.
- Evidence of central nervous system (CNS) metastases.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941330
|Grady Memorial Hospital
|Atlanta, Georgia, United States, 30303 |
|Emory University Hospital Midtown
|Atlanta, Georgia, United States, 30308 |
|Emory University Winship Cancer Institute
|Atlanta, Georgia, United States, 30322 |
||Elisavet Paplomata, MD
||Emory University Winship Cancer Institute
||Elisavet Paplomata, MD, Emory University
History of Changes
|Other Study ID Numbers:
WCI1534-08 ( Other Identifier: Other )
|Study First Received:
||July 15, 2009
|Results First Received:
||December 7, 2016
||February 24, 2017
Keywords provided by Emory University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 25, 2017
Neoplasms by Site
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists