Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

Not Recruiting

Trial ID: NCT00310180


This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

Official Title

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial

Stanford Investigator(s)

Irene Wapnir, MD
Irene Wapnir, MD

Professor of Surgery (General Surgery)


Inclusion Criteria:

   - Patients with operable histologically confirmed adenocarcinoma of the female breast
   who have completed primary surgical treatment and meet the following criteria:

      - ER and/or progesterone receptor (PR)-positive: Estrogen and/or progesterone
      receptor positive disease (as defined by local pathology laboratory)

      - Negative axillary nodes: As assessed by a sentinel lymph node biopsy, an axillary
      dissection, or both, and as defined by the Sixth Edition of the American Joint
      Committee on Cancer (AJCC) staging criteria

      - Tumor size 1.1-5.0 cm (or 5 mm-1.0 cm plus unfavorable histological features):

         - Unfavorable features defined as intermediate or poor nuclear and/or
         histologic grade, or lymphovascular invasion

         - NOTE: Definition of tumor size: The tumor size used for determination of
         eligibility is the pathologic tumor size, which is usually determined by the
         size of the tumor as measured by inspection of the gross specimen; if the
         tumor size is measured microscopically and the tumor includes ductal
         carcinoma in-situ, the measurement should include only the invasive
         component of the tumor

      - The tumor must be human epidermal growth factor receptor 2 (Her2)/neu negative by
      either fluorescent in-situ hybridization (FISH) or immunohistochemistry (e.g. 0
      or 1+ by DAKO Herceptest)

   - The patient and physician must be agreeable to initiate standard chemotherapy and
   hormonal therapy as adjuvant therapy

   - A tissue specimen from the primary breast cancer has been located and is ready to be
   shipped to the appropriate laboratory after consent is obtained and within 3 days
   following pre-registration; NOTE: For determination of the Oncotype Recurrence Score,
   tissue must be shipped to Genomic Health; if the Oncotype DX Recurrence Score was
   previously performed by Genomic Health (prior to pre-registration), tissue must be
   submitted to the Eastern Cooperative Oncology Group (ECOG)-American College of
   Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility upon

   - Leukocyte count >= 3500/mm^3

   - Platelets >= 100,000/mm^3

   - Serum creatinine =< 1.5 mg/dL

   - Serum aspartate transaminase (AST) that is =< 3-fold the upper institutional limits of

   - Patients must be disease-free of prior invasive malignancies for >= 5 years with the
   exception of curatively-treated basal cell or squamous cell carcinoma of the skin or
   carcinoma in situ of the cervix; patients with a previous ipsilateral or contralateral
   invasive breast cancer, or with bilateral synchronous cancers, are not eligible;
   patients with previous ipsilateral or contralateral ductal in situ carcinoma (DCIS)
   are not eligible

   - Prior treatment

      - Mandatory prior surgery criteria:

         - Patient must pre-register within 84 days from the final surgical procedure
         required to adequately treat the primary tumor (please note that if margins
         are not clear and a resection has to be conducted after pre-registration but
         before randomization, the patient will be deemed to be within the 84 day
         window allowed by protocol and therefore eligible)

         - All tumors should be removed by either a mastectomy or local excision plus
         an acceptable axillary procedure (i.e., sentinel lymph node biopsy, axillary
         dissection, or both); there must be adequate (at least 1 mm if margin width
         specified) tumor-free margins of resection (for invasive and ductal
         carcinoma in-situ) in order for the patients to be eligible; patients with
         lobular carcinoma in-situ involving the resection margins are eligible

      - Criteria re: other prior treatments:

         - No prior chemotherapy for this malignancy

         - No prior radiation therapy for this malignancy; this includes no prior
         MammoSite Brachytherapy radiation therapy (RT)

         - Hormonal therapy: Patients who develop breast cancer while receiving a
         selective estrogen-receptor modulator (SERM; e.g., tamoxifen, toremifene,
         raloxifene) or an aromatase inhibitor (e.g., anastrazole, letrozole,
         exemestane) for breast cancer prevention or a SERM for other indications
         (e.g., raloxifene for osteoporosis) are not eligible; however, patients may
         have received up to 8 weeks of a SERM or aromatase inhibitor for this
         malignancy and still be eligible for study entry

   - Patients must have an anticipated life expectancy of at least 10 years

   - Patients with the following medical conditions should not be enrolled on the study:

      - Chronic obstructive pulmonary disease requiring treatment

      - Chronic liver disease (e.g., cirrhosis, chronic active hepatitis)

      - Previous history of a cerebrovascular accident

      - History of congestive heart failure or other cardiac disease that would represent
      a contraindication to the use of an anthracycline (e.g., doxorubicin or

      - Chronic psychiatric condition or other condition that would impair compliance
      with the treatment regimen

   - Women must not be pregnant or breast-feeding; all females of childbearing potential
   must have a blood test or urine study within 2 weeks prior to pre-registration to rule
   out pregnancy

      - Women of childbearing potential must be strongly advised to utilize an accepted
      and effective form of non-hormonal contraception (e.g. intrauterine device,
      condoms, diaphragm, abstinence)

   - Patients must not have previously had the Oncotype DX Assay performed, with the
   exception of patients who have had the assay performed and have a recurrence score of


drug: exemestane

drug: letrozole

drug: anastrozole

other: Laboratory Biomarker Analysis

other: Quality-of-Life Assessment

radiation: Radiation Therapy

drug: Tamoxifen Citrate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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