Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy

Lobular Breast Carcinoma Clinical Trial

— PETBreast  

Official title:

Monitoring Response After The First Chemotherapy Cycle In Newly Diagnosed Breast Cancer As A Guide For Neoadjuvant Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01038258
• Other study ID #: CCAM 07
• Status: Active, not recruiting
• Phase: N/A
• First received: December 22, 2009
• Last updated: July 11, 2012
• Start date: July 2007
• Est. completion date: April 2013

Study information

• Verified date: July 2012
• Source: Auxilio Mutuo Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma, Ductal
• Carcinoma, Lobular
• Inflammatory Breast Carcinoma
• Invasive Ductal Carcinoma
• Lobular Breast Carcinoma

Intervention

Procedure:
• PET scan after course 1 and surgery after 8 courses
PET scan and surgery

Locations

Country	Name	City	State
Puerto Rico	Hospital Auxilio Mutuo Cancer Center	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
Auxilio Mutuo Cancer Center	Sononuclear

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic response		After 1st course of chemo and after definitive surgery	No