Immunotherapy with CFI-400945 for Breast Cancer

Recruiting at 5 trial locations

Overseen By Lesley Seymour

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Canadian Cancer Trials Group

Must not be taking: Growth factors, Full dose warfarin

Disqualifiers: Other malignancies, Infections, Cardiac, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CFI-400945 for breast cancer patients who have already had chemotherapy. The drug works by blocking a protein that helps cancer cells grow, potentially slowing down or killing the cancer cells.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot receive other anti-cancer treatments while on the trial. Additionally, certain drugs listed in Appendix V Table 1 are not allowed, and you should avoid certain fruits like grapefruit due to potential interactions with the study drug.

What makes the drug CFI-400945 unique for breast cancer treatment?

CFI-400945 is a novel drug that targets specific proteins involved in cancer cell division, offering a different approach compared to traditional chemotherapy or hormone therapies. This drug is part of a new wave of targeted therapies that aim to disrupt cancer cell growth with potentially fewer side effects. ^{1 2 3 4 5}

Research Team

David Cescon

Principal Investigator

Princess Margaret Cancer Centre, Toronto, ON

Rossanna Pezo

Principal Investigator

Sunnybrook Health Sciences Centre, Toronto, ON

Eligibility Criteria

This trial is for female patients over 18 with advanced/metastatic breast cancer who've had chemotherapy including anthracycline and taxane. They must be able to swallow pills, have no serious illnesses that could interfere with the study, and not be pregnant or breastfeeding. Participants need a life expectancy of at least 3 months, adequate organ function, and must agree to use contraception.

Inclusion Criteria

Patients must be willing to use a Pillsy medication event monitoring system

I have given permission for my tissue sample to be used for research.

Patients must have a life expectancy of 3 months or longer

Exclusion Criteria

I do not have any serious illnesses or infections that would prevent me from following the study's requirements.

I have had cancer before, but it was either skin cancer treated fully, cervical cancer treated without spreading, or any cancer treated over 2 years ago with no current signs of disease.

I have not used growth factors in the last 28 days and won't need them during the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CFI-400945 to assess its effects on advanced/metastatic breast cancer

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• CFI-400945

Trial Overview The trial tests CFI-400945 in women who have already undergone chemotherapy for breast cancer. It aims to see if this oral medication can further slow disease progression compared to standard treatments. Patients will use a Pillsy system for monitoring pill intake.

Participant Groups

Group I: Cohort 3: Not PTEN-null, ER+ and/or PR+, HER2- Experimental Treatment 1 Intervention

N=9 to 24 patients

Group II: Cohort 2: PTEN-null, ER+ and/or PR+, HER2- Experimental Treatment 1 Intervention

N=9 to 24 patients

Group III: Cohort 1: TNBC Experimental Treatment 1 Intervention

N=9 to 24 patients

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Stand Up To Cancer Canada-Canadian Cancer Society Breast Cancer Dream Team

Collaborator

Trials

1

Recruited

50+

Findings from Research

The combination of the FRα vaccine TPIV200 and the PD-L1 inhibitor durvalumab was well tolerated in 27 patients with advanced platinum-resistant ovarian cancer, showing a low grade 3 toxicity rate of 18.5%.

While the overall response rate was low (3.7% partial response and 33.3% stable disease), the median overall survival was notably long at 21 months, suggesting potential benefits from this immunotherapy approach in a heavily pretreated patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and clinical efficacy of durvalumab in combination with folate receptor alpha vaccine TPIV200 in patients with advanced ovarian cancer: a phase II trial. Zamarin, D., Walderich, S., Holland, A., et al.[2021]

Advancements in gene transfer technology have opened new avenues for developing immunotherapy for breast cancer, focusing on the transfer of genes that enhance immune function and target tumor antigens.

Immunotherapy is expected to be most effective when used alongside traditional treatments, particularly in targeting micrometastatic disease to lower the chances of cancer returning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gene therapy for carcinoma of the breast: Genetic immunotherapy. Strong, TV.[2019]

Breast cancer immunotherapy, particularly therapeutic vaccines, is being explored as a potential treatment option due to the severe side effects associated with conventional therapies, but no breast cancer vaccine has yet been approved for clinical use.

Current breast cancer vaccine strategies, including protein/peptide, dendritic cell, and genetic vaccines, often fail to provide clinical benefits on their own and are typically used in combination with other treatments like chemotherapy or radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer vaccines as a targeted immunotherapy approach for breast cancer: an update of clinical evidence. Abbaspour, M., Akbari, V.[2022]

The combination of ConvitVax, an autologous tumor cell vaccine, with anti-PD-1 therapy showed improved antitumor effects in a breast cancer model, evidenced by increased tumor necrosis and enhanced immune cell infiltration.

This study suggests that combining ConvitVax with checkpoint inhibitors like anti-PD-1 could lead to more effective and personalized breast cancer treatments, especially considering the vaccine's low cost and ease of preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a ConvitVax/anti-PD-1 combined immunotherapy for breast cancer treatment. Godoy-Calderón, MJ., González-Marcano, E., Carballo, J., et al.[2019]

References

1. Iran pubmed.ncbi.nlm.nih.gov

In silico Evaluation of PLAC1-fliC As a Chimeric Vaccine against Breast Cancer [2023]

2. England pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and clinical efficacy of durvalumab in combination with folate receptor alpha vaccine TPIV200 in patients with advanced ovarian cancer: a phase II trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Gene therapy for carcinoma of the breast: Genetic immunotherapy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Cancer vaccines as a targeted immunotherapy approach for breast cancer: an update of clinical evidence. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a ConvitVax/anti-PD-1 combined immunotherapy for breast cancer treatment. [2019]