Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
|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.
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|