Clinical Trials /

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer

NCT02003209

Description:

This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer that is operable or has spread from where it started to nearby tissue or lymph nodes (locally advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
  • Official Title: A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation

Clinical Trial IDs

  • ORG STUDY ID: NCI-2013-02228
  • SECONDARY ID: NCI-2013-02228
  • SECONDARY ID: NSABP-B-52
  • SECONDARY ID: NSABP-B-52
  • SECONDARY ID: U10CA012027
  • SECONDARY ID: U10CA180868
  • NCT ID: NCT02003209

Conditions

  • Estrogen Receptor Positive
  • HER2/Neu Positive
  • Progesterone Receptor Positive
  • Stage IB Breast Cancer AJCC v7
  • Stage IIA Breast Cancer AJCC v6 and v7
  • Stage IIB Breast Cancer AJCC v6 and v7
  • Stage IIIA Breast Cancer AJCC v7
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIC Breast Cancer AJCC v7

Interventions

DrugSynonymsArms
Aromatase Inhibition TherapyAromatase InhibitionArm II (chemo, estrogen deprivation, surgery, radiation)
CarboplatinBlastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, RibocarboArm I (combination chemotherapy, surgery, radiation)
DocetaxelDocecad, RP56976, Taxotere, Taxotere Injection ConcentrateArm I (combination chemotherapy, surgery, radiation)
Goserelin AcetateZDX, ZoladexArm II (chemo, estrogen deprivation, surgery, radiation)
Pertuzumab2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4, Perjeta, rhuMAb2C4, RO4368451Arm I (combination chemotherapy, surgery, radiation)
TrastuzumabABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, PF-05280014, rhuMAb HER2, RO0452317, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar PF-05280014, Trastuzumab-dkstArm I (combination chemotherapy, surgery, radiation)

Purpose

This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer that is operable or has spread from where it started to nearby tissue or lymph nodes (locally advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine whether the addition of estrogen deprivation to neoadjuvant therapy
      consisting of therapy of docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP) yields a
      greater rate of pathologic complete response (pCR) (breast and nodes) than TCHP alone when
      administered to women with operable, hormone receptor-positive, HER2-positive breast cancer.

      SECONDARY OBJECTIVES:

      I. To determine whether the addition of estrogen deprivation to neoadjuvant therapy
      consisting of TCHP will increase the pCR rate in the breast compared to TCHP alone when
      administered to women with operable, hormone receptor-positive, HER2-positive breast cancer.

      II. To determine whether the addition of estrogen deprivation to neoadjuvant therapy
      consisting of TCHP improves recurrence-free interval (RFI) in women with operable, hormone
      receptor-positive, HER2-positive breast cancer.

      III. To determine whether the addition of estrogen deprivation to neoadjuvant therapy
      consisting of TCHP improves overall survival (OS) in women with operable, hormone
      receptor-positive, HER2-positive breast cancer.

      IV. To compare the rates of second primary invasive cancer by treatment arm. V. Assessment of
      patterns of pCR, RFI, and OS by menopausal status. VI. To evaluate the cardiac toxicity
      associated with each of the regimens. VII. To compare the effect of adding estrogen
      deprivation to neoadjuvant therapy on endocrine-related symptoms in all patients by treatment
      arm.

      VIII. To compare the effect of adding estrogen deprivation to neoadjuvant therapy on
      vasomotor symptoms, musculoskeletal, and vaginal complaints as well as quality of life.

      IX. To determine a relationship between pCR and a potential mechanism of
      resistance/sensitivity in hormone receptor-positive, HER2-positive tumors.

      X. To evaluate tumor infiltrating lymphocytes (TILs) and immune biomarkers as predictors of
      pCR.

      XI. To study early changes in TILs and other immune biomarkers in response to TCHP.

      OUTLINE: Patients are randomized to 1 of 2 treatments arms.

      NEOADJUVANT:

      ARM I: Patients receive docetaxel intravenously (IV) over 60 minutes, carboplatin IV over
      30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1.
      Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to
      course 3 of treatment.

      ARM II: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I.
      Premenopausal patients also receive goserelin acetate subcutaneously (SC) every 28 days until
      surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day
      before surgery. Postmenopausal patients receive aromatase inhibition therapy at the
      investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment
      #4 undergo 2 core biopsies prior to course 3 of treatment.

      SURGERY: Patients undergo lumpectomy or mastectomy.

      RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.

      ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.

      After completion of study treatment, patients are followed up every 6, 9, 12, and 18 months
      for 5 years.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (combination chemotherapy, surgery, radiation)Active ComparatorNEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment. SURGERY: Patients undergo lumpectomy or mastectomy. RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery. ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
  • Carboplatin
  • Docetaxel
Arm II (chemo, estrogen deprivation, surgery, radiation)ExperimentalNEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment. SURGERY: Patients undergo lumpectomy or mastectomy. RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery. ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
  • Aromatase Inhibition Therapy
  • Carboplatin
  • Docetaxel
  • Goserelin Acetate

Eligibility Criteria

        Inclusion Criteria:

          -  Patients should have a life expectancy of at least 10 years, excluding their diagnosis
             of breast cancer; (comorbid conditions should be taken into consideration, but not the
             diagnosis of breast cancer)

          -  Women of reproductive potential must agree to use an effective non-hormonal method of
             contraception during study therapy (chemotherapy, trastuzumab, pertuzumab, and
             estrogen deprivation therapy) and for at least 7 months after the last dose of study
             therapy

          -  Submission of tumor samples is required for all patients; the local pathology
             department policy regarding release of tumor samples must be considered in the
             screening process; patients whose tumor samples are located in a pathology department
             that by policy will not submit any samples for research purposes should not be
             approached for participation in the B-52 trial

          -  The patient must have signed and dated an Institutional Review Board (IRB)-approved
             consent form that conforms to federal and institutional guidelines

          -  The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
             of 0 or 1

          -  Clinical staging for the primary tumor can be cT1c (must be 2.0 cm) or T2-T4 if
             clinically node negative; if the regional lymph nodes are cN1 and cytologically or
             histologically positive or if cN2-N3 with or without a biopsy, the primary breast
             tumor can be cT0-T4

          -  The diagnosis of invasive adenocarcinoma of the breast must have been made by core
             needle biopsy

          -  Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound,
             and/or magnetic resonance imaging [MRI]) within 6 weeks prior to randomization; if
             suspicious or abnormal, fine needle aspirate (FNA) or core biopsy is recommended, also
             within 6 weeks prior to randomization; findings of these evaluations will be used to
             determine the nodal status prior to randomization:

               -  Nodal status - negative

                    -  Imaging of the axilla is negative

                    -  Imaging is suspicious or abnormal but the FNA or core biopsy of the
                       questionable node(s) on imaging is negative

               -  Nodal status - positive

                    -  FNA or core biopsy of the node(s) is cytologically or histologically
                       suspicious or positive

                    -  Imaging is suspicious or abnormal but FNA or core biopsy was not performed

          -  Patients may be premenopausal or postmenopausal at the time of randomization; for
             study purposes, postmenopausal is defined as:

               -  Age 56 or older with no spontaneous menses for at least 12 months prior to study
                  entry; or

               -  Age 55 or younger with no spontaneous menses for at least 12 months prior to
                  study entry (e.g., spontaneous or secondary to hysterectomy) and with a
                  documented estradiol level in the postmenopausal range according to local
                  institutional/laboratory standard; or

               -  Documented bilateral oophorectomy

          -  The tumor must have been determined to be HER2-postive as follows:

               -  Immunohistochemistry (IHC) 3+ or

               -  In situ hybridization (ISH)-positive (defined by ratio of HER2 to circulating
                  endothelial progenitors [CEP]17 >= 2.0 or HER2 gene copy number >= 6 per nucleus)

          -  The tumor must have been determined to be estrogen receptor (ER) and/or progesterone
             (PgR) positive assessed by current American Society of Clinical Oncology
             (ASCO)/College of American Pathologist (CAP) guideline recommendations for hormone
             receptor testing; patients with >= 1% ER or PgR staining by IHC are considered
             positive

          -  Absolute neutrophil count (ANC) must be >= 1200/mm^3

          -  Platelet count must be >= 100,000/mm^3

          -  Hemoglobin must be >= 10 g/dL

          -  Total bilirubin must be =< upper limit of normal (ULN) for the lab unless the patient
             has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar
             syndrome involving slow conjugation of bilirubin

          -  Alkaline phosphatase must be =< 2.5 x ULN for the lab

          -  Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab

          -  Alkaline phosphatase and AST may not both be > the ULN; for example, if the alkaline
             phosphatase is > the ULN but =< 2.5 x ULN, the AST must be =< the ULN; if the AST is >
             the ULN but =< 1.5 x ULN, the alkaline phosphatase must be =< ULN; Note: If alanine
             aminotransferase (ALT) is performed instead of AST (per institution's standard
             practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be
             =< 1.5 x ULN

          -  Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the
             study if liver imaging (computed tomography [CT], MRI, positron emission tomography
             [PET]-CT, or PET scan) performed within 6 weeks prior to randomization does not
             demonstrate metastatic disease and the requirements are met

          -  Patients with alkaline phosphatase that is > ULN but =< 2.5 x ULN or unexplained bone
             pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan
             performed within 6 weeks prior to randomization does not demonstrate metastatic
             disease

          -  Within 6 weeks prior to randomization, the most recent serum creatinine must be =< ULN
             or measured or calculated creatinine clearance must be > 60 mL/min

          -  Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days
             prior to randomization; (LVEF assessment performed by 2-dimensional [2-D]
             echocardiogram is preferred; however, multi gated acquisition scan [MUGA] scan may be
             substituted based on institutional preferences); the LVEF must be >= 50% regardless of
             the cardiac imaging facility's lower limit of normal; note: since the pre-entry LVEF
             serves as the baseline for comparing subsequent LVEF assessments, it is critical that
             this baseline study be an accurate assessment; if the baseline LVEF is > 65%, the
             investigator is encouraged to have the accuracy of the initial LVEF result confirmed
             and repeat the test if the accuracy is uncertain

        Exclusion Criteria:

          -  FNA alone to diagnose the breast cancer

          -  Excisional biopsy or lumpectomy performed prior to randomization

          -  Surgical axillary staging procedure prior to randomization; pre-neoadjuvant therapy
             sentinel node biopsy is not permitted

          -  Definitive clinical or radiologic evidence of metastatic disease; (chest imaging
             [mandatory for all patients] and other imaging [if required] must have been performed
             within 90 days prior to randomization)

          -  Synchronous bilateral invasive breast cancer

          -  Synchronous or previous contralateral invasive breast cancer; (patients with
             synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] or lobular
             carcinoma in situ [LCIS] are eligible)

          -  Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS;
             (patients with synchronous or previous ipsilateral LCIS are eligible)

          -  Treatment including radiation therapy (RT), chemotherapy, targeted therapy, or
             endocrine therapy for the currently diagnosed breast cancer prior to randomization

          -  Previous endocrine therapy such as raloxifene or tamoxifen (or other selective
             estrogen receptor modulator [SERM]) or an aromatase inhibitor for any malignancy

          -  Previous therapy with anthracycline, taxanes, carboplatin, trastuzumab, or other HER2
             targeted therapies for any malignancy

          -  Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement
             therapy, etc. (these patients are eligible if this therapy is discontinued prior to
             randomization)

          -  History of non-breast malignancies (except for in situ cancers treated only by local
             excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior
             to randomization

          -  Cardiac disease (history of and/or active disease) that would preclude the use of the
             drugs included in the treatment regimens; this includes but is not confined to:

               -  Active cardiac disease:

                    -  Angina pectoris that requires the use of anti-anginal medication;

                    -  Ventricular arrhythmias except for benign premature ventricular
                       contractions;

                    -  Supraventricular and nodal arrhythmias requiring a pacemaker or not
                       controlled with medication;

                    -  Conduction abnormality requiring a pacemaker;

                    -  Valvular disease with documented compromise in cardiac function; and

                    -  Symptomatic pericarditis

               -  History of cardiac disease:

                    -  Myocardial infarction documented by elevated cardiac enzymes or persistent
                       regional wall abnormalities on assessment of left ventricular (LV) function;

                    -  History of documented congestive heart failure (CHF); and

                    -  Documented cardiomyopathy

          -  Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg
             or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if
             initiation or adjustment of BP medication lowers pressure to meet entry criteria)

          -  Active hepatitis B or hepatitis C with abnormal liver function tests

          -  Intrinsic lung disease resulting in dyspnea

          -  Poorly controlled diabetes mellitus

          -  Active infection or chronic infection requiring chronic suppressive antibiotics

          -  Patients known to be human immunodeficiency virus (HIV) positive with a baseline
             cluster of differentiation (CD)4 count of < 250 cells/mm^3 or have a history of
             acquired immune deficiency syndrome (AIDS) indicator conditions; patients taking
             anti-retroviral therapy that may have a potential overlapping toxicity with the study
             therapy are not eligible

          -  Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral
             sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events
             version 4.0 (CTCAE v4.0)

          -  Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel,
             or other disease significantly affecting gastrointestinal function

          -  Other non-malignant systemic disease that would preclude treatment with any of the
             treatment regimens or would prevent required follow-up

          -  Conditions that would prohibit administration of corticosteroids

          -  Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day
             methylprednisolone equivalent (excluding inhaled steroids)

          -  Known hypersensitivity to any of the study drugs or any of the ingredients or
             excipients of these drugs (e.g., polysorbate 80), including sensitivity to benzyl
             alcohol

          -  Pregnancy or lactation at the time of study entry; (note: pregnancy testing must be
             performed within 2 weeks prior to randomization according to institutional standards
             for women of childbearing potential)

          -  Psychiatric or addictive disorders or other conditions that, in the opinion of the
             investigator, would preclude the patient from meeting the study requirements

          -  Use of any investigational product within 30 days prior to randomization
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of pCR in the breast and post therapy lymph nodes
Time Frame:Up to 3.9 years
Safety Issue:
Description:Evaluated histologically, defined as the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy. The difference between the rates of pCR (breast and nodes) in the two treatment groups will be tested using the binomial test for the difference between two proportions. Logistic regression will be used to investigate the effect of treatments on pCR breast and pCR breast and nodes after adjusting for standard prognostic factors such as clinical tumor size, clinical nodal status, inflammatory breast cancer, and age.

Secondary Outcome Measures

Measure:Change in endocrine-related symptoms using Breast Cancer Prevention Trial (BCPT) symptom checklist
Time Frame:Baseline to up to 4 weeks after the last dose of chemotherapy
Safety Issue:
Description:It will be compared between the two treatment arms using repeated measures analysis of variance (ANOVA) with time as the within-patient factor and treatment group as the between-patient factor. All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:Change in greater vasomotor symptoms, musculoskeletal complaints, and vaginal problems, as measured by the subscale scores from the BCPT symptom checklist
Time Frame:Baseline to up to 6 weeks after last dose of chemotherapy
Safety Issue:
Description:All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:Change in QOL as measured by the Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) and the 12-item Short Form (SF-12) Physical Component Scale (PCS)
Time Frame:Baseline to up to 4 weeks after last dose of chemotherapy
Safety Issue:
Description:All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:Incidence of cardiac toxicity categorized according to National Cancer Institute CTCAE version 4.0
Time Frame:Up to 6 weeks post surgery
Safety Issue:
Description:All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:Levels of tumor-infiltrating lymphocytes
Time Frame:Up to 3.9 years
Safety Issue:
Description:All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:OS
Time Frame:Time from randomization until death from any cause, assessed up to 8.4 years
Safety Issue:
Description:Kaplan-Meier estimates of the percentages of patients free from recurrence and percentages surviving will be compared and proportional hazards models will be used to estimate and control for the effect of prognostic variables.
Measure:Patterns of OS by menopausal status
Time Frame:Up to 5 years
Safety Issue:
Description:All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:Patterns of pCR by menopausal status
Time Frame:Up to 3.9 years
Safety Issue:
Description:All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:Patterns of RFI by menopausal status
Time Frame:Up to 5 years
Safety Issue:
Description:All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:Rate of pCR in the breast
Time Frame:Up to 3.9 years
Safety Issue:
Description:Defined as the absence of any invasive component in the resected breast specimen. Logistic regression will be used to investigate the effect of treatments on pCR breast and pCR breast and nodes after adjusting for standard prognostic factors such as clinical tumor size, clinical nodal status, inflammatory breast cancer, and age.
Measure:Rate of second primary invasive cancer of any type
Time Frame:Time from randomization to the development of a second primary invasive cancer of any site excluding squamous and basal cell carcinoma of the skin, assessed up to 5 years
Safety Issue:
Description:The cumulative incidence rates of second primary cancers for the two treatment groups will be compared using the method described by Gray. All statistical testing will be performed using a two-tailed test with a Type I error of 0.05.
Measure:RFI
Time Frame:Time from surgery to invasive local, regional or distant recurrence, or death from breast cancer for patients with operable disease and for patients with inoperable progressive disease, assessed up to 8.4 years
Safety Issue:
Description:Kaplan-Meier estimates of the percentages of patients free from recurrence and percentages surviving will be compared and proportional hazards models will be used to estimate and control for the effect of prognostic variables.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:National Cancer Institute (NCI)

Last Updated

February 8, 2018