NCT01641406

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Auxilio Mutuo Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment propose of TEC-NAX for the triple negatives and for the Her2+ cases. For the Er+/Her2- cases, we propose to use the PET scan to guide therapy after the first course of TEC. Those who drop in SUV≤5%, will have their treatment modified by using the Oncotype test. Those Her2 negative patients whose response to the first 4 courses of induction TEC is less than a complete remission, will have their tretment changed to a second line regimen, Navelbine-Avastin-Xeloda(NAX), with the intention of capturing a better response prior to surgery. Those who are Her2+ will initially also receive TEC but subsequent therapy will include Trastuzumab(Herceptin) whether thet respond wellor not to TEC.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2012-07-16
• Last updated: 2012-07-16

Locations

1 site across 1 country: Puerto Rico