Trial Search Results

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer 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. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Anastrozole
  • Drug: Exemestane
  • Other: Laboratory Biomarker Analysis
  • Drug: Letrozole
  • Other: Quality-of-Life Assessment
  • Drug: Systemic Chemotherapy
  • Drug: Tamoxifen Citrate

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes)
   invasive breast carcinoma with positive estrogen and/or progesterone receptor status,
   and negative HER-2 status; estrogen and progesterone receptor positivity must be
   assessed according to American Society of Clinical Oncology (ASCO)/College of American
   Pathologists (CAP) guidelines as either estrogen receptor (ER) or progesterone
   receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be
   assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ
   hybridization (ISH) or both; HER-2 is negative if a single test (or all tests)
   performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using
   single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single
   probe or HER-2/CEP ration < 2.0 with an average copy number < 4.0 signals per cell by
   dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be
   performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2
   equivocal is not eligible

   - Patients with multifocal, multicentric and synchronous bilateral breast cancers are
   allowed

      - Multifocal disease is defined as more than one invasive cancer < 2 cm from the
      largest lesion within the same breast quadrant; (NOTE: the Oncotype DX testing
      must be completed on the largest lesion)

      - Multicentric disease is defined as more than one invasive cancer >= 2 cm from the
      largest lesion within the same breast quadrant or more than one lesion in
      different quadrants (NOTE: Oncotype DX testing should be completed on all tumors
      and the determination for eligibility should be made on the highest recurrence
      score)

      - Synchronous bilateral disease is defined as invasive breast cancer with positive
      lymph nodes (axillary or intramammary) in at least one breast, diagnosed within
      30 days of each other; (NOTE: the Oncotype DX testing should be completed on both
      tumors and the tumor with the highest recurrence score should be used)

   - Patients will have undergone axillary staging by sentinel node biopsy or axillary
   lymph nodes dissection (ALND); patients must have at least one, but no more than three
   known positive lymph nodes (pN1a, pN1b or pN1c); patients with micrometastases as the
   only nodal involvement (pN1mi) are not eligible; patients with positive sentinel node
   are not required to undergo full axillary lymph node dissection; this is at the
   discretion of the treating physician; axillary node evaluation is to be performed per
   the standard of care at each institution

   - Patients must not have inflammatory breast cancer and must not have metastatic disease

   - Patients with a prior diagnosis of contralateral ductal carcinoma in situ (DCIS) are
   eligible if they underwent a mastectomy or lumpectomy with whole breast radiation;
   prior partial breast irradiation, including brachytherapy, is not allowed; patients
   with a prior diagnosis of ipsilateral DCIS or invasive breast cancer who received
   radiation to that breast are not eligible

   - Patients must have had either breast-conserving surgery with planned radiation therapy
   or total mastectomy (with or without planned postmastectomy radiation); patients must
   have clear margins from both invasive breast cancer and DCIS (as per local
   institutional guidelines); lobular carcinoma in situ (LCIS) at the margins is allowed

   - Registration of patients who have not yet undergone Oncotype DX screening must occur
   no later than 56 days after definitive surgery; (for all patients, Step 2 Registration
   must occur within 84 days after definitive surgery); if the Oncotype DX Breast Cancer
   Assay has not been performed, patients must be willing to submit tissue samples for
   testing to determine the Recurrence Score value; a representative block or unstained
   sections from the representative block are sent directly to Genomic Health for
   Oncotype DX Breast Cancer Assay which will be performed according to the standard
   commercial process

      - If the Oncotype DX Recurrence Score is already known and is 25 or less, the
      patient must be registered to Step 2 immediately following Step 1 registration;
      if the Oncotype DX Recurrence Score is already known and is greater than 25, the
      patient is ineligible

   - Patients must have a complete history and physical examination within 28 days prior to
   registration

   - Patients must have a performance status of 0-2 by Zubrod criteria

   - Patients must be able to receive taxane and/or anthracycline based chemotherapy

   - Patients must not have begun chemotherapy or endocrine therapy for their breast cancer
   prior to registration

   - Patients must not require chronic treatment with systemic steroids (inhaled steroids
   are allowed) or other immunosuppressive agents

   - Patients must not have received an aromatase inhibitor (AI) or a selective estrogen
   receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to
   registration

   - Patients must not be pregnant or nursing; women of reproductive potential must have
   agreed to use an effective contraceptive method; a woman is considered to be of
   "reproductive potential" if she has had menses at any time in the preceding 12
   consecutive months; in addition to routine contraceptive methods, "effective
   contraception" also includes heterosexual celibacy and surgery intended to prevent
   pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
   bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
   previously celibate patient chooses to become heterosexually active during the time
   period for use of contraceptive measures outlined in the protocol, he/she is
   responsible for beginning contraceptive measures

   - No other prior malignancy is allowed except for adequately treated basal cell (or
   squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the
   patient has been disease-free for 5 years

   - The Quality of Life and Economic Substudy is permanently closed to accrual effective
   12/1/12; patients who consented to QOL prior to 12/1/12 should continue to complete
   QOL forms per their expectation report; patients who are able to complete a
   questionnaire in English must be offered the opportunity to participate in the Quality
   of Life and Economic Substudy; (The Quality of Life and Economic Substudy is available
   to U.S. INSTITUTIONS ONLY); patients who are not able to complete a questionnaire in
   English are registered to S1007 without participating in the Quality of Life and
   Economic Substudy

      - Patients who consent to participate in the Quality of Life and Economic Substudy
      and who do not yet know the results of their Oncotype DX screening must agree to
      complete the S1007 Health-Related Quality of Life Questionnaire: Enrollment
      between 14 days prior to and 7 days after Step 1 Registration

      - Patients who consent to participate in the Quality of Life and Economic Substudy
      and who do already know their Oncotype DX Recurrence Score (and it is 25 or less)
      will proceed to Step 2 Registration without completing the S1007 Health-Related
      Quality of Life Questionnaire Enrollment Form (but will complete the S1007
      Health-Related Quality of Life Questionnaire: Randomized Study Form)

   - Patients or their legally authorized representative must be informed of the
   investigational nature of this study and must sign and give written informed consent
   in accordance with institutional and federal guidelines; for Step 1 registration of
   patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay,
   the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2
   registration of patients whose Recurrence Score is already known and is 25 or less,
   the appropriate consent form is the Step 2 Consent Form

   - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
   treating institution's identity is provided in order to ensure that the current
   (within 365 days) date of institutional review board approval for this study has been
   entered in the system

   - STEP 2 REGISTRATION

   - Recurrence score (RS) by Oncotype DX must be =< 25

   - Step 2 Registration must take place within 84 days after definitive surgery; patients
   must not have begun chemotherapy or endocrine therapy for their breast cancer prior to
   randomization

   - Patients randomized to either arm may also co-enroll in phase III trials that compare
   local therapies, or compare systemic therapies (such as chemotherapy, if randomized to
   Arm I of S1007)

   - The Quality of Life and Economic Substudy is permanently closed to accrual effective
   12/1/12; patients at U.S. INSTITUTIONS who consent to participate in the Quality of
   Life and Economic Substudy must agree to complete the S1007 Health-Related Quality of
   Life Questionnaire: Randomized Study Form after Recurrence Score results and
   randomized treatment status are known but before treatment has been initiated

   - Patients or their legally authorized representative must be informed of the
   investigational nature of this study and must sign and give written informed consent
   in accordance with institutional and federal guidelines; for all patients the
   appropriate consent form for this registration is the Step 2 Consent

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting