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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038258
Recruitment Status : Unknown
Verified July 2012 by Fernando Cabanillas, Auxilio Mutuo Cancer Center.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2009
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
Fernando Cabanillas, Auxilio Mutuo Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Invasive Ductal Carcinoma Lobular Breast Carcinoma Inflammatory Breast Carcinoma Procedure: PET scan after course 1 and surgery after 8 courses Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No arms
No arms
Procedure: PET scan after course 1 and surgery after 8 courses
PET scan and surgery

Primary Outcome Measures :
  1. Pathologic response [ Time Frame: After 1st course of chemo and after definitive surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038258

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

Responsible Party: Fernando Cabanillas, Hematology-Oncologist, Auxilio Mutuo Cancer Center Identifier: NCT01038258     History of Changes
Other Study ID Numbers: CCAM 07
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Fernando Cabanillas, Auxilio Mutuo Cancer Center:
neoadjuvant chemotherapy

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