NCT01038258

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

4.4 years

First QC Date

December 22, 2009

Last Update Submit

July 11, 2012

Conditions

Invasive Ductal CarcinomaLobular Breast CarcinomaInflammatory Breast Carcinoma

Keywords

neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic response

    After 1st course of chemo and after definitive surgery

Study Arms (1)

No arms

OTHER

No arms

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

Interventions

PET scan after course 1 and surgery after 8 coursesPROCEDURE

PET scan and surgery

No arms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • years of age.
  • Available for follow-up visits
  • Able to comply with study requirements.
  • Have signed an IRB approved written informed consent form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Auxilio Mutuo Cancer Center

San Juan, Puerto Rico, 00919, Puerto Rico

Location

MeSH Terms

Conditions

Carcinoma, LobularInflammatory Breast Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fernando Cabanillas, MD

    Hospital Auxilio Mutuo Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hematology-Oncologist

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

July 1, 2007

Primary Completion

December 1, 2011

Study Completion

April 1, 2013

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

PR(1)