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

NCT01641406 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-07-16

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab

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.

DRUG

Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab

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".

DRUG

Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab

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.

Sponsors & Collaborators

  • Auxilio Mutuo Cancer Center

    lead OTHER

Principal Investigators

  • Fernando Cabanillas, MD · Auxilio Mutuo Hospital Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-01-31
Completion
2013-03-31

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01641406 on ClinicalTrials.gov