FLT PET/CT Imaging for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Pennsylvania

Must be taking: Ribociclib, Paclitaxel

Disqualifiers: Pregnancy, Imaging intolerance, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Cycle 1: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a special imaging technique, PET/CT, can track breast cancer activity when it spreads to other parts of the body. An experimental tracer called FLT enhances the visibility of cancer cells on the scan. Participants will also receive treatment with two cancer drugs, Paclitaxel and Ribociclib, to assess their combined effectiveness with the imaging. This trial may suit individuals with breast cancer that has spread beyond the liver and bones and is visible on regular scans. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this PET/CT imaging technique is safe for evaluating breast cancer?

Research has shown that a new imaging method called [18F]FLT PET/CT is being tested to better understand breast cancer cell growth. This method uses a special tracer, [18F]fluorothymidine (FLT), to highlight cancer activity. Although [18F]FLT remains under study, it resembles other imaging methods already used for breast cancer, which are generally considered safe.

The main treatments in the study are paclitaxel and ribociclib. Paclitaxel, a chemotherapy drug, has been used for many years to treat various cancers, including breast cancer. Most patients tolerate it well, though some may experience side effects like hair loss or tiredness. Ribociclib, another well-known drug, is often used with other breast cancer treatments. It is usually well-tolerated, but some people might experience side effects such as nausea or low blood cell counts.

These treatments have a well-understood safety record, providing a strong basis for their use in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FLT PET/CT imaging technique for breast cancer because it offers a new way to visualize and track tumor activity in real-time. Unlike standard imaging methods, which often focus on tumor size, this technique uses a radioactive tracer, [18F]FLT, to highlight cell proliferation, providing more detailed insights into how the cancer is actually behaving. This could lead to faster and more accurate assessments of how well treatments like Paclitaxel and Ribociclib are working, potentially allowing for more personalized and timely adjustments to therapy.

What evidence suggests that FLT PET/CT imaging is effective for evaluating proliferative activity in metastatic breast cancer?

Research has shown that a special type of scan called [18F]FLT PET/CT, which participants in this trial will receive, effectively measures tumor activity in breast cancer. This scan highlights areas where cancer cells actively grow and divide. Studies indicate that [18F]FLT-PET is useful for assessing chemotherapy effectiveness, particularly in aggressive types like triple-negative breast cancer. It provides clear images that help doctors distinguish between cancerous tissue and normal or inflamed tissue, making it a promising tool for evaluating treatment effectiveness in patients. ^{1 3 6 7 8}

Who Is on the Research Team?

David Mankoff, MD, PHD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults with metastatic breast cancer that tests positive for the Rb protein. They must be able to receive ribociclib and paclitaxel treatment, have at least one tumor outside of liver and bone detectable by standard imaging, and provide informed consent. Pregnant women or those with serious health or psychological issues are excluded.

Inclusion Criteria

Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

My breast cancer has been confirmed by tests and shows Rb protein.

I have breast cancer that has spread to an area other than the liver or bones.

Exclusion Criteria

Ineligible for the therapeutic trial UPCC 06115

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo [18F]FLT PET/CT imaging to evaluate proliferative activity in metastatic disease sites

1 week

3 visits (in-person)

Treatment

Participants receive ribociclib (LEE011) and weekly Paclitaxel therapy

Cycle 1: 3 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FLT
• Paclitaxel
• PET/CT
• Ribociclib

Trial Overview The study is testing how well a special type of PET/CT scan using [18F]FLT can show the growth activity in metastatic breast cancer sites. Participants will also be treated with the chemotherapy drug paclitaxel and the targeted therapy ribociclib.

How Is the Trial Designed?

Group I: FLT PET/CT Experimental Treatment 4 Interventions

All subjects will receive an \[18F\]FLT PET/CT scan.

Paclitaxel is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in European Union as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in Canada as Paclitaxel for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Paclitaxel (TAXOL) therapy presents unique challenges and side effects that require careful management by healthcare professionals, particularly nurses, to ensure patient safety and treatment success.

The review emphasizes the importance of a collaborative nursing plan that identifies specific toxicities associated with paclitaxel and outlines interventions to mitigate these side effects during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing considerations in paclitaxel (Taxol) administration. Lubejko, BG., Sartorius, SE.[2015]

Ribociclib, a CDK 4/6 inhibitor, significantly improves median progression-free survival (PFS) in women with HR+/HER2- metastatic breast cancer when used in combination with endocrine therapy, with PFS ranging from 8 to 13 months across three phase III trials.

The treatment is well tolerated, particularly in elderly patients, and while it has some dose-limiting toxicities like neutropenia and QTc prolongation, it maintains health-related quality of life and reduces pain scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ribociclib in HR+/HER2- Advanced or Metastatic Breast Cancer Patients. Rascon, K., Flajc, G., De Angelis, C., et al.[2020]

Paclitaxel (Taxol) is a significant new chemotherapy drug for breast cancer, showing promise in both single-agent and combination treatments.

Ongoing research at Memorial Sloan-Kettering Cancer Center aims to optimize the use of paclitaxel in various treatment settings, including metastatic and adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memorial Sloan-Kettering Cancer Center experience with paclitaxel in the treatment of breast cancer. Seidman, AD., Hudis, CA., Fennelly, D., et al.[2015]

In a phase II study involving 43 patients with non-small-cell lung cancer, Abraxane (260 mg/m2) demonstrated a 16% overall response rate and a 49% disease control rate, indicating its efficacy as a first-line therapy.

Abraxane was well tolerated, with no severe hypersensitivity reactions reported and only 5% of patients discontinuing treatment due to mild toxicities, suggesting a favorable safety profile for this novel formulation of paclitaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abraxane, a novel Cremophor-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer. Green, MR., Manikhas, GM., Orlov, S., et al.[2022]

A 55-year-old woman developed corneal disorders, including blurred vision and epithelial defects, after treatment with nab-paclitaxel, indicating that this microtubule inhibitor can cause significant ocular side effects.

After discontinuing nab-paclitaxel, her corneal condition improved dramatically, suggesting that the drug was the likely cause of her symptoms, although the potential contribution of other medications like trastuzumab and pertuzumab should also be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Case of a Corneal Disorder after Breast Cancer Treatment with Nab-paclitaxel]. Hosotani, Y., Morimatsu, T., Takata, M., et al.[2016]

In a study of 33 patients with progressive or recurrent non-small cell lung cancer (NSCLC) who had previously undergone platinum-based chemotherapy, Abraxane showed a partial response rate of 33.3%, with better outcomes in patients with squamous cell carcinoma (41.7% response) compared to those with adenocarcinoma (21.1%).

The treatment demonstrated a disease control rate of 75.8% and a median progression-free survival of five months, with manageable side effects, indicating that Abraxane is a potentially effective option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Abraxane in treatment of progressive and recurrent non-small cell lung cancer patients: A retrospective clinical study. Yuan, DM., Lv, YL., Yao, YW., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354408/

Comparing the diagnostic efficacy of [18F]FDG PET/CT and ... In diagnosing recurrence in breast cancer at the patient level, [18F]FDG PET/CT demonstrated a pooled sensitivity of 0.93 (95% CI: 0.88–0.96), ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0959804915011260

A systematic review on [18F]FLT-PET uptake as a measure ... This systematic review focuses on the use of [ 18 F]FLT-PET tumour uptake values as a measure of tumour response to therapeutic interventions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9955497/

The Role of PET/CT in Breast Cancer - PMC - PubMed Central This review discusses the role of 18 F-FDG PET and other PET tracers beyond FDG in breast cancer imaging.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1476558625000636

[18F]-FLT-PET to evaluate how the sequencing of ... Our study demonstrates that [18F]-FLT-PET imaging can serve as an approach to evaluate the efficacy of chemotherapy dose sequencing in triple-negative breast ...

5. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-019-0579-5

Dual time point [18F]FLT-PET for differentiating proliferating ... For differentiating tumor from inflammation and normal tissues, fluorodeoxyglucose ([18F]FDG) dual time point PET could be helpful.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8458550/

Benefits and harms of implementing [18F]FDG-PET/CT for ... [18F]FDG-PET/CT reported breast cancer metastases in 72 of 225 women (32.0%), and metastases were verified by biopsy in 52 (52/225, 23.1%). Prior probability ...

7. nature.com nature.com/articles/bjc2014207

Evaluation of FLT-PET-CT as an imaging biomarker ... [18F]fluorothymidine (FLT) has been proposed as a positron emission tomography (PET)-imaging biomarker of proliferation for breast cancer.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/38/NCT02274038/Prot_SAP_000.pdf

Serial [18F]Fluorothymidine (FLT)PET/CT as a Biomarker ... • Evaluation of [18F]fluorothymidine ([18F]FLT) as an imaging tracer for PET/CT ... user, complete imaging data could be generated. Prior to positioning on ...