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

NCT01641406 | Unknown Phase 2 DMC

• 1 other identifier: NAC CCAM 11-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NAC Protocol; NAC and Oncotype Guided Hormonal therapy for breast cancer; Neoadjuvant and Oncotype; NAC CCAM 1101

Outcome Measures

Primary Outcomes (1)

• The primary objective is to obtain a RCB rate of 0-1 in at least 66%

  The primary objective is to raise the RCB rate of 0-1 to ≥40%. the startegy of using Oncotype test to guide NAC therapy will be considered encouraging for future testing if we are able to achieve this goal.

  2 years

Study Arms (3)

ER- (Triple Neg. and ER- PR+ Her 2 -)

EXPERIMENTAL

Experimental chemotherapy using neoadjuvant approach

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

Her 2 +

EXPERIMENTAL

Experimental chemotherapy using neoadjuvant approach

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

ER + (ER+ PR+ Her 2- / ER+ PR- Her 2 -)

EXPERIMENTAL

Experimental chemotherapy using neoadjuvant approach

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

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.

Also known as: Neoadjuvant chemotherapy for breast cancer

ER- (Triple Neg. and ER- PR+ Her 2 -)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated (no chemotherapy, hormonal or radiation therapy)invasive breast cancer.
• Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinoma will also be elegible.
• Age≥ 18 years
• Only female patients are eligible
• Tumor≥ 1.0cm by MRI and/or sonographic or clinical exam measurements. If the tumor is \<1.0 but the patient has biopsy proven lymph node metastasis, she will also be considered eligible.Although only tumors≥2cm are consideredmeasurable by RECIST criteria, we will nevertheless include tumors≥1cm since the primary endpoint is pathological CR rate.
• Performance status ECOG≤2 or Karnofsky≥ 50%
• Peripheral neuropathy≤ grade 1
• Hematologic (minimal values):Absolute Neutrophil count≥1,500/mm³; Hemoglobin≥8.0g/dl; Paltelet count≥100,000/mm³
• Hepatic; Total bilirubin≤ULN AST and ALT and ALP do not have to be within the range. In determining eligibility the more abnormal of the two values(AST or ALT) should be use as per protocol table on p.24of 69.
• Women of childbearing potential must have a negative pregnancy test
• Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
• Renal;urine protein:creatinine(UPC)ratio1.0 at screening or urine dipstick for proteinuria\<2+(patients discovered to have˃/=2+ protinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate\</=1g of protein in 24 hrs to be elegible

You may not qualify if:

• Pregnant or breast feeding patients are excluded
• Patients with second malignancies with expected survival\<5 years
• Previous chemotherapy with Taxanes,Anthracyclines or Cyclophosphamide.
• Patientes with history of severe hypersensitivity reaction to Taxotere(Docetaxel)or other drugs formulated with polysorbate 80.
• Pure DCIS diagnoses are not elegible
• Special histologies with favorable prognosis such as mucinous, tubular are not elegible
• Patients with reduced ejection fraction\<50% are not eligible
• Patients with tumors\<1.0cm unless biopsy proven axillary node metastasis present.
• Cardiac thrombotic events in the past 12 months
• Stroke or transient ischemic attacks (TIA) within 12 months
• poorly controlled hypertension defined as persistent blood pressure elevation˃150 systolic and/or 100 diastolic not responsive to medications.
• GI condition that increases risk of perforation within 6 months of study
• Any serious non-healing wound, ulcer, or bone fracture.
• No minor surgical procedure within 7 days of study entry or major surgery within 28 days of study entry or anticipation of need for major surgical procedure during the course of the study.
• Significant vascular disease such as symptomatic peripheral vascular disease.

Sponsors & Collaborators

• Auxilio Mutuo Cancer Center: lead

Study Sites (1)

Hospital Auxilio Mutuo Cancer Center

San Juan, PR, 00918, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ; Carcinoma, Lobular; Inflammatory Breast Neoplasms

Interventions

Docetaxel; Epirubicin; Cyclophosphamide; Vinorelbine; Capecitabine; Trastuzumab; Bevacizumab; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Combined Modality Therapy; Therapeutics

Study Officials

• Fernando Cabanillas, MD

  Auxilio Mutuo Hospital Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Cabanillas, MD

CONTACT

787-758-2000; fcabanil@mdanderson.org

Idalia Liboy, MD

CONTACT

787-758-2000; iliboy@auxiliomutuo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematolgist-Oncologist

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 16, 2012
• Study Start: March 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

PR (1)