Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy (PETBreast)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Auxilio Mutuo Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sononuclear
Information provided by (Responsible Party):
Fernando Cabanillas, Auxilio Mutuo Cancer Center
ClinicalTrials.gov Identifier:
NCT01038258
First received: December 22, 2009
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

A PET scan drop less than 20% in SUVs or below a certain absolute SUV value after the first course of neoadjuvant chemotherapy can predict pathological response, and could in the future lead to an early surgical intervention.


Condition Intervention
Invasive Ductal Carcinoma
Lobular Breast Carcinoma
Inflammatory Breast Carcinoma
Procedure: PET scan after course 1 and surgery after 8 courses

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Monitoring Response After The First Chemotherapy Cycle In Newly Diagnosed Breast Cancer As A Guide For Neoadjuvant Therapy

Resource links provided by NLM:


Further study details as provided by Auxilio Mutuo Cancer Center:

Primary Outcome Measures:
  • Pathologic response [ Time Frame: After 1st course of chemo and after definitive surgery ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2007
Estimated Study Completion Date: April 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No arms
No arms
Procedure: PET scan after course 1 and surgery after 8 courses
PET scan and surgery

Detailed Description:

The use of neo-adjuvant systemic therapy in women recently diagnosed with breast cancer is growing in popularity based on its proven benefit (1). Pre-operative chemotherapy not only can assist in regards to breast conservation therapy (2) but data suggest prognostic benefits in those subset of patient's obtaining complete pathological response (3,4) .

It is imperative for clinicians to detect as early as possible those patients likely to obtain the desired clinical and /or pathologic response, thus identifying those patients who don't benefit from the first line neoadjuvant treatment so that their treatment can be modified accordingly.

Response to treatment based on clinical data or structural imaging, usually requires several chemotherapeutic cycles to establish degree of effectiveness (5). Lately, FDG-PET/CT has been used in different types of neoplasms, breast cancer among them, to establish early response to treatment (6,7). Recent data has established the usefulness of metabolic analysis via FDG-PET, in separating subgroups of chemotherapy. For such analytical approach, sequential estimation of SUVs (Standardized Uptake Value) have been measured along the duration of the treatment. Reduction in SUVs presumes adequate response to treatment (8), while little or no change in metabolic activity presumes sub-optimal response .

However, no definite consensus has been established in regards to what degree of metabolic response is predictive of the desired clinical benefit, particularly early in the treatment . Establishing such criteria could potentially serve as a guideline for monitoring neoadjuvant treatment. Schelling et al, was able to separate a group of patients that eventually showed either progression of the disease or no clinical response as early as the first course of chemotherapy.

The aim of our study is to establish a simple formula using FDG-PET/CT, as early as the first course of chemotherapy, to stratify patients undergoing neoadjuvant chemotherapy for recently diagnosed breast cancer. Those who will benefit from continuing the same treatment will be regarded as responders versus non-responders, which are those in need of changing strategy.

The primary goal of this study is to correlate the results of FDG-PET/CT performed 15 days after the first course of chemotherapy versus those of clinical assessment and breast MRI obtained after the 3rd course of chemotherapy. At that time, a clinical decision on which therapeutic path to be followed will be made.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recently diagnosed breast carcinoma that will receive neoadjuvant chemotherapy based on: Tumors size greater than 2 cms; Locally advanced tumors, Tumors close to or invading chest wall or areola and/or Inflammatory Breast cancer.
  • 18 years of age.
  • Available for follow-up visits
  • Able to comply with study requirements.
  • Have signed an IRB approved written informed consent form

Exclusion Criteria:

  • Any significant medical or psychiatric illness, which would prevent the patient from giving informed consent or following the study procedures.
  • Pregnant and Nursing women.
  • No restriction will be placed on the chemotherapy regimen used although we expect that most patients will receive Anthracycline based regimens.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038258

Locations
Puerto Rico
Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00919
Sponsors and Collaborators
Auxilio Mutuo Cancer Center
Sononuclear
Investigators
Principal Investigator: Fernando Cabanillas, MD Hospital Auxilio Mutuo Cancer Center
  More Information

No publications provided

Responsible Party: Fernando Cabanillas, Hematology-Oncologist, Auxilio Mutuo Cancer Center
ClinicalTrials.gov Identifier: NCT01038258     History of Changes
Other Study ID Numbers: CCAM 07
Study First Received: December 22, 2009
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Auxilio Mutuo Cancer Center:
neoadjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Lobular
Inflammatory Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on August 20, 2014