Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy (PETBreast)
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|ClinicalTrials.gov 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
|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|
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)|
|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|
Procedure: PET scan after course 1 and surgery after 8 courses
PET scan and surgery
- Pathologic response [ Time Frame: After 1st course of chemo and after definitive surgery ]
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 ClinicalTrials.gov identifier (NCT number): NCT01038258
|Hospital Auxilio Mutuo Cancer Center|
|San Juan, Puerto Rico, 00919|
|Principal Investigator:||Fernando Cabanillas, MD||Hospital Auxilio Mutuo Cancer Center|