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

18 Years
Open (Enrolling)
Invasive Ductal Carcinoma, Lobular Breast Carcinoma, Inflammatory Breast Carcinoma

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Trial Information

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

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Pathologic response

Outcome Time Frame:

After 1st course of chemo and after definitive surgery

Safety Issue:


Principal Investigator

Fernando Cabanillas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Auxilio Mutuo Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

April 2013

Related Keywords:

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