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

Study ID: PACCT-1NCT Number: NCT00310180Trial Title: NCTN: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx TrialTrial Description: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. You are encouraged to view the PDF data dictionaries found in the "Documents" tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication.ECOG-ACRIN Cancer Research GroupSubmitted in collaboration with the NCTN/NCORP Data ArchiveData presented in the following publication(s):PMID 29860917PMID 32271671Disease type(s): Breast Neoplasm - Breast Cancer - InvasiveAvailable Dataset(s):NCT00310180-D1 (PMID 29860917): This dataset contains the data published in the primary results publication for TAILORx (PACCT-1; NCT00310180; PMID 29860917). The dataset includes patient characteristics, OncoType Recurrence Score values, survival outcomes, and stratification variables used in the analyses presented in the publication. The data reflect the study database as of March 2, 2018. All patients who were registered to one of the arms are included.NCT00310180-D4 (PMID 32271671): There are three separate submissions for PMID 32271671, a publication analyzing the cognitive function among women with early breast cancer on ECOG-ACRIN trial PACCT-1. This dataset submission, NCT00310180-D4, contains additional clinical data in addition to those submitted in NCT00310180-D1 (for the trial's primary publication with PMID 29860917). Dataset NCT00310180-D5 contains the FACT-COG data. Dataset NCT00310180-D6 contains the FACT-G data. The data contained within variables identical to those presented in NCT00310180-D1 are not duplicated in this submission.NCT00310180-D5 (PMID 32271671): There are three separate submissions for PMID 32271671, a publication analyzing the cognitive function among women with early breast cancer on ECOG-ACRIN trial PACCT-1. This dataset submission, NCT00310180-D5, contains the FACT-COG data. Dataset NCT00310180-D4 contains additional clinical data in addition to those submitted in NCT00310180-D1 (for the trial's primary publication with PMID 29860917). Dataset NCT00310180-D6 contains the FACT-G data. The data contained within variables identical to those presented in NCT00310180-D1 are not duplicated in this submission.NCT00310180-D6 (PMID 32271671): There are three separate submissions for PMID 32271671, a publication analyzing the cognitive function among women with early breast cancer on ECOG-ACRIN trial PACCT-1. This dataset submission, NCT00310180-D6, contains the FACT-G data. Dataset NCT00310180-D4 contains additional clinical data in addition to those submitted in NCT00310180-D1 (for the trial's primary publication with PMID 29860917). Dataset NCT00310180-D5 contains the FACT-COG data. The data contained within variables identical to those presented in NCT00310180-D1 are not duplicated in this submission.Forthcoming Dataset(s): NCT00310180-D2, NCT00310180-D3]]>
PACCT-1 Primary Analysis Clinical Data DescriptionPACCT-1 Additional Clinical Data DescriptionPACCT-1 FACT-COG Data DescriptionPACCT-1 FACT-G Data DescriptionInclusion 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 criteriaTumor 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 invasionNOTE: 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 tumorThe 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 therapyA 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 randomizationLeukocyte count >= 3500/mm^3Platelets >= 100,000/mm^3Serum creatinine =< 1.5 mg/dLSerum aspartate transaminase (AST) that is =< 3-fold the upper institutional limits of normalPatients 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 eligiblePrior treatmentMandatory 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 eligibleCriteria re: other prior treatments:No prior chemotherapy for this malignancyNo 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 entryPatients must have an anticipated life expectancy of at least 10 yearsPatients with the following medical conditions should not be enrolled on the study:Chronic obstructive pulmonary disease requiring treatmentChronic liver disease (e.g., cirrhosis, chronic active hepatitis)Previous history of a cerebrovascular accidentHistory of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline (e.g., doxorubicin or epirubicin)Chronic psychiatric condition or other condition that would impair compliance with the treatment regimenWomen 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 pregnancyWomen 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 11-25]]>