What side effects are associated with this type of intervention?

Common side effects of investigational cancer drugs, including kinase inhibitors like CFI-402257, often include fatigue, nausea, diarrhea, and hematologic toxicities such as neutropenia and anemia. Fulvestrant, an estrogen receptor antagonist, typically causes hot flashes, injection site reactions, fatigue, and gastrointestinal disturbances. Both types of treatments may also lead to more severe but less common side effects, which should be monitored by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of breast cancer that are similar to Fulvestrant, an estrogen receptor antagonist. These include aromatase inhibitors like letrozole and anastrozole, which are used in hormone receptor-positive breast cancer. Additionally, targeted therapies such as CDK 4/6 inhibitors (e.g., palbociclib) in combination with endocrine therapy have been approved. For HER2-positive breast cancer, combinations like trastuzumab with lapatinib or pertuzumab have shown efficacy. Investigational drugs and novel targeted therapies continue to be explored in clinical trials to improve outcomes for breast cancer patients.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: <ol> <li>Trastuzumab Deruxtecan (Enhertu): An antibody-drug conjugate targeting HER2-positive breast cancer, showing significant efficacy in clinical trials.</li> <li>Alpelisib (Piqray): A PI3K inhibitor used in combination with endocrine therapy for HR-positive, HER2-negative breast cancer with PIK3CA mutations.</li> <li>Sacituzumab Govitecan (Trodelvy): An antibody-drug conjugate targeting Trop-2, approved for triple-negative breast cancer.</li> <li>Pembrolizumab (Keytruda): An immune checkpoint inhibitor used in combination with chemotherapy for triple-negative breast cancer.</li> <li>Olaparib (Lynparza): A PARP inhibitor for patients with BRCA-mutated, HER2-negative breast cancer.</li> </ol>

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TTK Inhibitor

CFI-402257 + Fulvestrant for Breast Cancer

Phase 1 & 2

Recruiting

Led By R Wesolowski

Research Sponsored by Treadwell Therapeutics, Inc

Eligibility Criteria Checklist

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

Must have

Part A Escalation: Have histological or cytological proof of advanced cancer that has progressed on at least 1 prior line of systemic therapy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

Study Summary

This trial is testing an investigational drug to see if it is safe to use alone or with another drug to treat people with advanced solid tumors or advanced breast cancer.

Who is the study for?

This trial is for adults with advanced solid tumors or breast cancer that's positive for estrogen/progesterone receptors but negative for HER2. They must have tried certain therapies before, like a CDK4/6 inhibitor and possibly one line of endocrine therapy or chemotherapy. People can't join if they have brain cancer, serious heart conditions, are pregnant/nursing, had recent treatments/surgery, infections, blood clots or coagulopathy.Check my eligibility

What is being tested?

The study tests CFI-402257 alone in various advanced cancers and combined with Fulvestrant specifically in advanced breast cancer patients. It aims to determine the safety of these treatments and how well they work against these cancers.See study design

What are the potential side effects?

Potential side effects aren't listed here but generally could include typical reactions to cancer drugs such as nausea, fatigue, risk of infection due to lowered immunity; specific side effects would be detailed based on the drug's action.

Eligibility Criteria

Inclusion Criteria

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

Select...

My advanced cancer has worsened despite previous treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the incidence of adverse events of CFI-402257 as a single agent and at the recommended phase 2 dose (RP2D)

To assess the incidence of adverse events of CFI-402257 in combination with fulvestrant and at the recommended phase 2 dose (RP2D)

Secondary outcome measures

Assessment of objective response rates

Assessment of objective response rates of the combination

Assessment of the pharmacokinetic profile of CFI-402257 in combination with fulvestrant through AUC

+2 more

Side effects data

From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803

50%

DECREASED APPETITE

30%

CONSTIPATION

30%

DIARRHOEA

30%

PAIN IN EXTREMITY

30%

RASH

20%

NASOPHARYNGITIS

20%

FATIGUE

20%

ANAEMIA

20%

ANGINA PECTORIS

20%

OEDEMA PERIPHERAL

20%

GAMMA-GLUTAMYLTRANSFERASE INCREASED

20%

HEADACHE

20%

COUGH

10%

BLOOD ALKALINE PHOSPHATASE INCREASED

10%

GASTROOESOPHAGEAL REFLUX DISEASE

10%

ASPARTATE AMINOTRANSFERASE INCREASED

10%

BLOOD CREATININE INCREASED

10%

INFLUENZA

10%

NAUSEA

10%

PLATELET COUNT DECREASED

10%

CONTUSION

10%

HYPERTRIGLYCERIDAEMIA

10%

LYMPHOCYTE COUNT DECREASED

10%

DYSPEPSIA

10%

DRY MOUTH

10%

PNEUMONIA

10%

HERPES ZOSTER

10%

ARTHRALGIA

10%

HYPOCALCAEMIA

10%

HYPERKALAEMIA

10%

EYE OEDEMA

10%

BRADYCARDIA

10%

CORONARY ARTERY DISEASE

10%

MYOCARDIAL ISCHAEMIA

10%

PLEURAL EFFUSION

10%

PNEUMOTHORAX

10%

INCREASED TENDENCY TO BRUISE

10%

LEUKOPENIA

10%

NEUTROPENIA

10%

HYPOTHYROIDISM

10%

ABDOMINAL PAIN

10%

ASTHENIA

10%

FACE OEDEMA

10%

PYREXIA

10%

INTERNATIONAL NORMALISED RATIO INCREASED

10%

ARTHRITIS

10%

MUSCLE SPASMS

10%

MUSCULOSKELETAL PAIN

10%

NEURALGIA

10%

INSOMNIA

10%

RESTLESSNESS

10%

DYSPNOEA

10%

DYSPNOEA EXERTIONAL

10%

PRODUCTIVE COUGH

10%

PRURITUS

10%

SKIN LESION

100%

80%

60%

40%

20%

Study treatment Arm

Dovitinib

Dovitinib+Fulvestrant

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Combination Escalation and ExpansionExperimental Treatment2 Interventions

Dose selection and expansion of CFI-402257 with Fulvestrant

Group II: Part A: Monotherapy Escalation and ExpansionExperimental Treatment1 Intervention

Dose selection and expansion of CFI-402257

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

FDA approved

0 / 1Eligibility 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

Fulvestrant, an estrogen receptor antagonist, binds to estrogen receptors on breast cancer cells, blocking estrogen and promoting receptor degradation, thereby inhibiting cancer cell growth. Similar treatments include aromatase inhibitors, which reduce estrogen production, and selective estrogen receptor modulators (SERMs) like tamoxifen, which block estrogen receptors in breast tissue. These therapies are vital for hormone receptor-positive breast cancer patients as they target the hormonal pathways that drive cancer growth, improving treatment outcomes and survival rates.

Emerging data on the efficacy and safety of fulvestrant, a unique antiestrogen therapy for advanced breast cancer.