Trial Outcomes & Findings for FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer (NCT NCT01931709)

NCT ID: NCT01931709

Last Updated: 2023-11-18

Results Overview

The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as: 1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0) 2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: At time of surgery
• Results posted on: 2023-11-18

Participant Flow

Participant milestones

Measure	Diagnostic (FDG PET and DCE-MRI) Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

Baseline characteristics by cohort

Measure	Diagnostic (FDG PET and DCE-MRI) n=35 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies
Clinical stage IIA	9 Participants n=5 Participants
Clinical stage IIB	8 Participants n=5 Participants
Clinical stage IIIA	9 Participants n=5 Participants
Clinical stage IIIB	3 Participants n=5 Participants
Clinical stage IIIC	6 Participants n=5 Participants
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At time of surgery

The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as:

1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0)

2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)

Outcome measures

Measure	Diagnostic (FDG PET and DCE-MRI) n=35 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies	Patients Without Favorable Pathologic Response Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease).
Number of Participants With Favorable Pathologic Response at Surgery	11 Participants	—

SECONDARY outcome

Timeframe: Baseline to up to 12 weeks (mid-therapy)

Population: Three participants had to be excluded from this analysis: 1. mid-therapy PET images got lost due to a technical error; 2. pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes; 3. pathologic response could not be evaluated due to a metastatic disease progression prior to surgery.

Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.

Outcome measures

Measure	Diagnostic (FDG PET and DCE-MRI) n=10 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies	Patients Without Favorable Pathologic Response n=22 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease).
Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response	-71.2 percent change Interval -87.8 to -6.6	-55.8 percent change Interval -87.3 to 1035.2

SECONDARY outcome

Timeframe: Baseline to up to 12 weeks (mid-therapy)

Population: Three participants had to be excluded from this analysis: 1. mid-therapy PET images got lost due to a technical error; 2. pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes; 3. pathologic response could not be evaluated due to a metastatic disease progression prior to surgery.

Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.

Outcome measures

Measure	Diagnostic (FDG PET and DCE-MRI) n=10 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies	Patients Without Favorable Pathologic Response n=22 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease).
Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response	-45.0 percent change Interval -98.1 to 289.2	-68.5 percent change Interval -99.2 to 21.9

SECONDARY outcome

Timeframe: The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status.

Population: At the time of final analysis, 7 of the 35 patients (20%) had recurrence.

Mean (range)

Outcome measures

Measure	Diagnostic (FDG PET and DCE-MRI) n=7 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies	Patients Without Favorable Pathologic Response Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease).
Time From Surgery to Breast Cancer Recurrence	2.9 years- recurrence free Interval 0.4 to 7.5	—

SECONDARY outcome

Timeframe: Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive.

Population: At the time of final analysis, 4 of the 35 patients (11%) had died.

Mean (range)

Outcome measures

Measure	Diagnostic (FDG PET and DCE-MRI) n=4 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies	Patients Without Favorable Pathologic Response Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease).
Time of Surgery to Overall Survival	3.1 years- overall survival Interval 1.2 to 7.5	—

SECONDARY outcome

Timeframe: Baseline to up to 12 weeks (mid-therapy)

Population: One participant had to be excluded from this analysis: \[1\] pathologic response could not be evaluated due to a metastatic disease progression prior to surgery.

Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.

Outcome measures

Measure	Diagnostic (FDG PET and DCE-MRI) n=11 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies	Patients Without Favorable Pathologic Response n=23 Participants Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease).
Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response	-31 percent change Interval -49.0 to -5.0	-14 percent change Interval -63.0 to 9.0

Adverse Events

Diagnostic (FDG PET and DCE-MRI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Specht, MD

University of Washington

Phone: 206-288-6889

Email: jspecht@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place