"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"

Sponsor
Auxilio Mutuo Cancer Center
Study ID
NCT01641406
Phase
PHASE2
Status
Unknown

Conditions

  • Infiltrating Duct and Lobular Carcinoma In Situ
  • Inflammatory Breast Carcinoma
  • Invasive Lobular Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab — DRUG
    ER-(Triple Negative and ER-PR+Her-2-):Patients who respond to the first 4 courses of TEC with a Complete Remission will receive 4 more courses of TEC. Patients who respond to the first 4 courses of TEC with a Partial Remission or Stable Disease will then have their treatment changed to the non-cross resistant NAX regimen.Courses will be repeated every 21 days according to blood counts.A total of 4 courses will be given.
  • Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab — DRUG
    Her-2 positive cases:Patients who respond to 4 courses of TEC with either a partial or complete remission will then receive 4 additional courses of Docetaxel plus Herceptin, and upon completion of the 4th course of DH they will undergo definitive surgery.A total of 4 courses will be given. Courses will be repeated every 21 days according to blood counts. Patients whose response after 4 courses of TEC is either stable disease or progression, will be treated with "NTX".
  • Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab — DRUG
    ER+ Cases(ER+PR+Her-2- and ER+PR-Her-2-):After the first course of TEC if the SUV of the primary tumor is \>5%, treatment will be TEC x 4 courses. If the Oncotype is low, patients will be switched to hormonal therapy x 6 months. If the Oncotype result is intermediate/high, patients will be NAX chemotherapy x 4 courses. If the SUV post course #1 TEC is \<5%, subsequent treatment will depend on the Oncotype.If the Oncotype is low, the treatment will be hormonal therapy x 6 months. If the Oncotype is intermediate/high , the treatment will be NAX chemotherapy x 4. Surgery will be performed 6 weeks after the 4th course of NAX chemotherapy.

Study Details

The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To evaluate the prognostic factors associated associated with pathological response as measured by the residual cancer burden tool.

Key Dates

First listed
Jul 16, 2012
Start date
Mar 31, 2011
Status verified
Jul 2012
Primary completion
Jan 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ER- (Triple Neg. and ER- PR+ Her 2 -)
    Experimental chemotherapy using neoadjuvant approach
  • Experimental: Her 2 +
    Experimental chemotherapy using neoadjuvant approach
  • Experimental: ER + (ER+ PR+ Her 2- / ER+ PR- Her 2 -)
    Experimental chemotherapy using neoadjuvant approach

Primary Outcome Measure

The primary objective is to obtain a RCB rate of 0-1 in at least 66% [ Time Frame: 2 years ]

Central Contacts

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