What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, endocrine therapy, and targeted therapy, have various side effects. Chemotherapy can cause nausea, fatigue, hair loss, and increased risk of infections. Endocrine therapy, like tamoxifen or aromatase inhibitors, may lead to hot flashes, bone density loss, and cardiovascular risks. Targeted therapies, such as trastuzumab, can result in heart problems, fatigue, and infusion reactions. Imaging techniques like FDG-PET/CT used to assess treatment response generally have minimal side effects, primarily related to radiation exposure.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that target metabolic pathways and utilize imaging for response assessment. One notable example is the use of FDG-PET/CT scans, which employ a radioactive glucose analog to detect metabolic activity in cancer cells, aiding in the evaluation of treatment response. Additionally, drugs like trastuzumab (Herceptin) and pertuzumab (Perjeta) have been approved for HER2-positive breast cancer, often used in combination with chemotherapy. These treatments, along with hormone therapies like tamoxifen and aromatase inhibitors, form the cornerstone of breast cancer management, providing targeted and effective options for patients.

What other types of research exist?

Promising novel alternatives to FDG-PET/CT for breast cancer patients include integrated PET/MRI using non-FDG-based tracers developed against specific targets, such as HER2 or estrogen receptors. These tracers can provide more specific information about tumor biology and response to targeted therapies. Additionally, whole-body MRI is emerging as a sensitive modality for detecting metastatic lesions, particularly in bone-dominant metastatic breast cancer.

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FDG-PET/CT Assessment for Breast Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for breast cancer include chemotherapy, hormone therapy, and targeted therapy. Chemotherapy kills rapidly dividing cells, including cancer cells, by damaging their DNA or inhibiting cell division. Hormone therapy blocks hormones like estrogen that fuel hormone receptor-positive breast cancers. Targeted therapies, such as HER2 inhibitors, specifically target molecular changes in cancer cells. These mechanisms are important for breast cancer patients as they help in selecting effective treatments based on the cancer's characteristics and predicting response to therapy, which can be monitored using FDG-PET/CT scans.

Phase 2

Waitlist Available

Led By Jennifer M Specht

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically confirmed metastatic breast cancer by local assessment that is hormone receptor positive by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and with known HER2 status

Patient must meet institutional guidelines for renal function for MRI and CT scanning

Must not have

Patients with RECIST 1.1 measurable lesions in viscera, active central nervous system (CNS), leptomeningeal carcinomatous or pleural or peritoneal disease will not be eligible

Patients who have received greater than 3 lines of cytotoxic chemotherapy for metastatic breast cancer are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years after study registration

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well certain scans work in assessing the response of patients with breast cancer that has spread to the bones. The scans use a special substance to highlight active cancer areas on detailed body images, helping doctors see if the treatment is working. These scans have been used successfully for various stages and evaluations of breast cancer.

Who is the study for?

This trial is for patients with breast cancer that has spread to the bones. Participants must have a life expectancy of at least 24 weeks, an ECOG performance status of <=2, and meet renal function guidelines. They should plan to receive specific systemic therapies like endocrine therapy or chemotherapy. Pregnant or breastfeeding women, those with certain other cancers or who've had extensive chemotherapy are excluded.

What is being tested?

The FEATURE study is testing how well FDG-PET/CT scans measure activity in bone-dominant metastatic breast cancer before and after treatment compared to standard imaging tests. This phase II trial aims to improve diagnostic accuracy for assessing responses in these patients.

What are the potential side effects?

While this trial focuses on diagnostic procedures rather than treatments, FDG-PET/CT involves exposure to radiation which carries risks such as a very small increase in the chance of developing cancer later in life.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer has spread, is hormone receptor positive, and my HER2 status is known.

Select...

My kidney function is good enough for MRI and CT scans.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My cancer is mainly in my bones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has not spread to my brain, membranes around the brain and spine, or filled my chest or abdomen cavities.

Select...

I have not had more than 3 chemotherapy treatments for my advanced breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years after study registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years after study registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years after study registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) response criteria as a binary predictor of progression-free survival (PFS)

Secondary study objectives

Ability of FDG-PET/CT metrics to predict OS in patients with BD MBC

PET/CT scan

Ability of FDG-PET/CT metrics to predict time to SRE in patients with BD MBC

+4 more

Other study objectives

Automated image analysis of FDG-PET/CT

Defining of criteria for selection of FDG-avid bone lesions for analysis based on thresholds for SULpeak or SUVmax

Exploration of alternative methods for measuring metabolic response with FDG-PET/CT to predict clinical endpoints in patients with BD MBC

Side effects data

From 2011 Phase 2 trial • 55 Patients • NCT00062374

65%

Fatigue

64%

Hypocalcemia

60%

Nausea

58%

White blood cell count decrease

56%

Neutrophil count decrease

55%

Hemoglobin decrease

45%

Diarrhea

38%

Platelet count decreased

36%

Hyponatremia

31%

Hypophosphatemia

29%

Hypokalemia

29%

Anorexia

27%

Abdominal pain/cramping

22%

Hypomagnesemia

22%

Vomiting

20%

Hyperglycemia

20%

Hyperkalemia

20%

Lymphocyte count decrease

20%

Neuropathy-sensory

20%

Hypoalbuminemia

18%

Alanine aminotransferase increase

13%

Dyspnea

13%

Aspartate aminotransferase increase

11%

Dehydration

11%

Creatinine

11%

Dizziness

11%

Edema

Thrombosis

Alopecia

Hypernatremia

Weight loss

Hearing impaired

Constipation

Dyspepsia

Mood alteration/anxiety

Taste disturbance

Febrile neutropenia

Dysphagia

Pain, other

Hypoglycemia

Pharyngeal mucositis

Hemorrhage, NOS

CNS/cerebrovascular ischemia

Chest pain

Seizure

Cardiovascular, other

Muscle weakness

Gastrointestinal disorder

Hypotension

Creatinine increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm I

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (FDG-PET/CT)Experimental Treatment3 Interventions

Patients receive FDG IV and undergo PET/CT scan over 15-30 minutes at baseline (within 21 days before start of standard systemic treatment) and at 12 weeks after start of standard systemic treatment in the absence of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include chemotherapy, hormone therapy, and targeted therapy. Chemotherapy kills rapidly dividing cells, including cancer cells, by damaging their DNA or inhibiting cell division. Hormone therapy blocks hormones like estrogen that fuel hormone receptor-positive breast cancers. Targeted therapies, such as HER2 inhibitors, specifically target molecular changes in cancer cells. These mechanisms are important for breast cancer patients as they help in selecting effective treatments based on the cancer's characteristics and predicting response to therapy, which can be monitored using FDG-PET/CT scans.

Role of 2-[18F]-fluorodeoxyglucose (FDG) positron emission tomography (PET) in the early assessment of response to chemotherapy in metastatic breast cancer patients.