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ARM A: Patients will be treated with exemestane.

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).

Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Cytoxan

Elisavet Paplomata, MD

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.

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.

Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

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)

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.

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.

Pfizer

Emory University

ARM A: Patients will be treated with exemestane.

Exemestane: 25 mg daily by mouth for 6 to 12 months.

A: Exemestane

ARM B: Patients will be treated with docetaxel and cytoxan.

Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers	NCT00941330	Breast Cancer	Exemestane Docetaxel Cytoxan	18 Years -	Emory University
Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers	NCT00941330	Breast Cancer	Exemestane Docetaxel Cytoxan	18 Years -	Emory University

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