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Clinical Trials (PDQ®)

Phase II Study of PET-Guided Neoadjuvant Chemotherapy and Oncotype-Guided Hormonal Therapy in Women With Previously Untreated Invasive Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

PET-Guided Chemotherapy and Hormone Therapy in Treating Women With Previously Untreated Invasive Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, Diagnostic, TreatmentUnknown18 and overOtherCCAM-11-01
CCAM 11-01, NCT01330212

Objectives

Primary

  1. To evaluate a novel neoadjuvant regimen by using the MD Anderson residual cancer burden score in treating patients with invasive breast cancer.

Secondary

  1. To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment in these patients.
  2. To prospectively evaluate the Oncotype test as a tool to stratify ER-positive/HER2-negative patients after treatment.
  3. To evaluate the clinical anti-tumor activity of neoadjuvant hormonal therapy in ER-positive/HER2-negative patients.
  4. To evaluate the prognostic factors associated with pathological response as measured by the residual cancer burden tool.

Entry Criteria

Disease Characteristics:

  • Diagnosis of invasive breast carcinoma, including any of the following subtypes:
    • Invasive ductal breast carcinoma
    • Invasive lobular breast carcinoma
    • Ductal carcinoma in situ (DCIS)
    • Inflammatory breast cancer

  • No pure DCIS diagnosis or histologies with favorable prognosis (e.g., mucinous or tubular histologies)

  • Measurable disease, defined as primary tumor size ≥ 1.0 cm by MRI, and/or sonographic, or clinical exam or tumors < 1.0 cm and biopsy-proven axillary lymph node metastasis present

  • Previously untreated disease

  • Estrogen and progesterone receptor status known

  • HER2 negative or positive

Prior/Concurrent Therapy:

  • No prior chemotherapy, hormonal therapy, or radiotherapy for invasive breast cancer
  • No prior taxanes, anthracyclines, or cyclophosphamide
  • No minor surgical procedure within the past 7 days
  • No major surgery within the past 28 days or anticipation of need for major surgery during the course of this study

Patient Characteristics:

  • Menopausal status not specified
  • ECOG performance status (PS) 0-2 or Karnofsky PS 50-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin normal
  • Urine protein:creatinine ratio < 1.0
    • Patients with proteinuria ≥ 2+ at baseline must undergo a 24-hour urine collection that demonstrates ≤ 1 g of protein/24 hr
  • Meets 1 of the following criteria:
    • AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN)
    • AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
    • AST or ALT ≤ 5 times ULN AND AP normal
  • No peripheral neuropathy ≥ grade 2
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
  • Not pregnant or nursing
  • No other malignancy within the past 5 years
  • No known severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
  • No other serious illness or medical condition, including any of the following:
    • Cardiac thrombotic event within the past 12 months
    • Stroke or transient ischemic attack within the past 12 months
    • Poorly controlled hypertension, defined as persistent blood pressure > 150 mm Hg systolic and/or 100 mm Hg diastolic that is not responsive to medications
    • Significant vascular disease (e.g., symptomatic peripheral vascular disease)
    • Gastrointestinal condition that increases risk of perforation within 6 months of study
    • Any serious non-healing wound, ulcer, or bone fracture
    • Evidence of bleeding diathesis or coagulopathy
  • Ejection fraction ≥ 50%

Expected Enrollment

60

Outcomes

Primary Outcome(s)

Pathological response rate as measured by MD Anderson residual cancer burden (RCB) score

Secondary Outcome(s)

Utility of the PET scan to guide the neoadjuvant treatment
Oncotype test as a tool to stratify ER-positive/HER2-negative patients after treatment
Clinical anti-tumor activity of neoadjuvant hormonal therapy in ER-positive/HER2-negative patients
Prognostic factors associated with pathological response as measured by the residual cancer burden tool

Outline

Patients are divided according to receptor status: Her2+ (includes ER+, ER-, and PR+) vs ER- (includes triple negative and ER/PR/Her2-) vs ER+ (includes ER+/PR+/Her2- and ER+/PR-/Her2-). Patients are assigned to 1 of 3 treatment groups.

All patients, regardless of receptor status, receive docetaxel IV over 60 minutes, epirubicin hydrochloride IV over 15-20 minutes, and cyclophosphamide IV over 20-30 minutes on day 1 (TEC regimen). For ER+/Her2- patients, subsequent therapy after TEC course 1 depends on Oncotype score. For other patients, treatment with TEC repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

  • Her2+ (includes ER+, ER-, and PR+): Patients are evaluated after 4 courses of TEC therapy. Patients who achieve complete remission (CR) or partial remission (PR) receive docetaxel IV over 60 minutes and trastuzumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 4 courses, followed by surgery with sentinel node biopsy and/or axillary dissection. Patients with progressive disease (PD) or stable disease (SD) after TEC receive vinorelbine tartrate IV over 60 minutes on days 1 and 8; trastuzumab IV over 60 minutes on day 1; and oral capecitabine twice daily on days 1-14 (NTX regimen). Treatment with NTX repeats every 21 days for 4 courses, followed by surgery with sentinel node biopsy and/or axillary dissection. After surgery, patients receive radiotherapy (when indicated) and maintenance trastuzumab for 1 year. ER-positive or PR-positive patients also receive hormonal therapy for 5 years.

  • ER- ( includes triple negative or ER-/PR+/Her2-): Patients are evaluated after 4 courses of TEC therapy. Patients who achieve CR receive 4 more courses of TEC and undergo surgery with sentinel node biopsy and/or axillary dissection. Patients who achieve PR or stable disease (SD) receive vinorelbine tartrate IV over 60 minutes on days 1 and 8; bevacizumab IV over 90 minutes on days 1 and 8; and oral capecitabine twice daily on days 1-14 (NAX regimen). Treatment with NAX repeats every 21 days for 4 courses in the absence of disease progression or toxicity. Approximately 28 days after the last dose of bevacizumab, patients proceed to surgery with sentinel node biopsy, and/or axillary dissection.

  • ER+ (includes ER+/PR+/Her2- or ER+/PR-/Her2-) : Patients undergo a PET scan 2 weeks after finishing 1 course of TEC therapy. If the drop of measured standardized uptake value (SUV) of primary tumor is > 5%, patients receive 3 additional courses of TEC therapy followed by additional therapy depends on the the Oncotype results. If the drop of measured SUV of primary tumor is ≤ 5% (after 1 course of TEC therapy), patients receive additional therapy depends on the Oncotype results.
    • Low Oncotype recurrence score: Patients receive hormonal therapy for 6 months, followed by surgery.

    • Intermediate or high Oncotype recurrence score: Patients receive NAX chemotherapy for 4 courses. Approximately 6 weeks after completion of course 4, patients undergo surgery.

    All patients in this group receive hormonal therapy for a total of 5 years (counting from the first dose).

After completion of study treatment, patients are followed up periodically.

Trial Contact Information

Trial Lead Organizations

Centro de Cancer del Hospital Auxilio Mutuo

Fernando Cabanillas, MD, Principal investigator
Ph: 787-758-2000
Email: fcabanil@mdanderson.org

Registry Information
Official Title Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer: CCAM 11-01
Trial Start Date 2011-03-03
Trial Completion Date 2013-03-04 (estimated)
Registered in ClinicalTrials.gov NCT01330212
Date Submitted to PDQ 2011-03-16
Information Last Verified 2011-04-04

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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