Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
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|ClinicalTrials.gov Identifier: NCT00941330|
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Exemestane Drug: Docetaxel Drug: Cytoxan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941330
|United States, Georgia|
|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|
|Principal Investigator:||Elisavet Paplomata, MD||Emory University Winship Cancer Institute|