Clinical Trial: Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Monitoring Response After The First Chemotherapy Cycle In Newly Diagnosed Breast Cancer As A Guide For Neoadjuvant Therapy
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.
Detailed Summary:
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 cours
Sponsor: Auxilio Mutuo Cancer Center
Current Primary Outcome: Pathologic response [ Time Frame: After 1st course of chemo and after definitive surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Auxilio Mutuo Cancer Center
Dates:
Date Received: December 22, 2009
Date Started: July 2007
Date Completion: April 2013
Last Updated: July 11, 2012
Last Verified: July 2012
