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

Must not have

Have the following cardiovascular conditions: uncontrolled severe hypertension, symptomatic congestive heart failure, active angina pectoris or recent myocardial infarction, chronic atrial fibrillation or QTc of greater than 470 msec

Have had prior treatment with a TTK/MPS1 inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial tests a new drug, CFI-402257, alone and with Fulvestrant in patients with advanced solid tumors and advanced breast cancer. It aims to determine if the drug is safe and effective by studying its effects on the body and cancer cells. Fulvestrant is an established treatment for hormone receptor-positive advanced breast cancer, often used in combination with other therapies to improve outcomes.

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.

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.

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

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My advanced cancer has worsened despite previous treatment.

Exclusion Criteria

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

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I do not have severe uncontrolled high blood pressure, heart failure symptoms, chest pain, recent heart attack, constant irregular heartbeat, or a long QT interval.

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I have been treated with a TTK/MPS1 inhibitor before.

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I have not had blood clotting issues or a history of them in the last 6 months.

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I have another active cancer besides my primary one.

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I currently have a serious infection.

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I have a brain tumor or cancer that has spread to my brain.

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I am currently on a full dose of warfarin.

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

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

Primary study objectives

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 study objectives

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 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Headache

17%

Diarrhea

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Obesity

10%

Flu like symptoms

Pain in extremity

Constipation

Fever

Bone pain

Dizziness

Dyspepsia

Hot flashes

Pruritus

Pain

Dysgeusia

Abdominal pain

Respiratory infection

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Dislocation of hip

Renal failure

Bronchial infection

Urinary tract infection

Thromboembolic event

Osteonecrosis of jaw

Palmar-plantar erythrodysesthesia syndrome

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

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 / 8Eligibility 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.