What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as hormone therapies and chemotherapy, have various side effects. Letrozole, an aromatase inhibitor, can cause bone density loss, fractures, and cardiovascular risks. Fulvestrant, an estrogen receptor antagonist, may lead to injection site pain, hot flashes, and fatigue. Chemotherapy agents like paclitaxel can result in neuropathy, myelosuppression, and alopecia. These treatments aim to manage cancer but often come with significant side effects that need to be monitored and managed.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer similar to those being studied with PF-06873600 include hormone therapies and targeted therapies. Letrozole, an aromatase inhibitor, and fulvestrant, an estrogen receptor antagonist, are commonly used in hormone receptor-positive (HR+) breast cancer. Other notable FDA-approved drugs include tamoxifen, another estrogen receptor modulator, and targeted therapies like trastuzumab for HER2-positive breast cancer. These treatments aim to inhibit cancer cell growth by interfering with hormone signaling or targeting specific proteins involved in cancer progression.

What other types of research exist?

Promising novel alternatives to PF-06873600 for breast cancer patients in 2024 include: 1) HER2-targeted therapies like trastuzumab deruxtecan and pyrotinib for HER2-positive breast cancer. 2) PI3K inhibitors such as alpelisib for HR+/HER2- breast cancer with PIK3CA mutations. 3) mTOR inhibitors like everolimus combined with hormone therapy for HR+ breast cancer. 4) CDK4/6 inhibitors like palbociclib, ribociclib, and abemaciclib for HR+/HER2- breast cancer. 5) Immunotherapies such as pembrolizumab for triple-negative breast cancer (TNBC).

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PF-06873600 + Hormone Therapy for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

• Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy

Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC)

Must not have

Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases

Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called PF-06873600 for people with advanced cancers. The medicine can be taken alone or with hormone treatments. It aims to stop cancer growth and may work better when combined with hormone therapy. PF-06873600 belongs to a class of drugs that has shown significant progress in improving outcomes for certain types of advanced breast cancer when combined with hormone treatments.

Who is the study for?

This trial is for people with certain advanced cancers, including HR+ HER2- breast cancer, triple negative breast cancer, and ovarian/fallopian tube/peritoneal cancers. Participants should have had prior treatments like CDK 4/6 inhibitors or chemotherapy but not be currently undergoing other trials or recent surgeries.

What is being tested?

The study tests PF-06873600 alone or with hormone therapies (letrozole taken daily by mouth or fulvestrant given as a monthly shot) in patients with specific types of advanced cancer. The treatment period lasts at least 7 to 8 months with weekly clinic visits.

What are the potential side effects?

Possible side effects are not detailed here but may include typical reactions to oral medications and hormone therapy such as gastrointestinal issues, fatigue, hormonal imbalances, injection site reactions, and potential drug-specific adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I've had CDK 4/6 inhibitor and hormone therapy, plus 1 or 2 chemotherapy treatments.

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I have advanced ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.

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My cancer can be measured or is not responding to current treatments.

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I have metastatic triple negative breast cancer and received up to 2 chemotherapy treatments.

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I have been diagnosed with metastatic triple negative breast cancer.

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My breast cancer is hormone receptor positive and HER2 negative.

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My breast cancer is HR+ and HER2- and I've had specific prior treatments.

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I have advanced ovarian, fallopian tube, or peritoneal cancer resistant to platinum therapy, with 2-3 prior treatments.

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I have had 1 or 2 chemotherapy treatments before.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have active and uncontrolled brain metastases.

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I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 3 years.

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I have not had major surgery or radiation in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 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

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2

Number of Participants With Dose Limiting Toxicities (DLTs) - Part 1

Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2

+4 more

Secondary study objectives

Accumulation Ratio Based on AUC (Rac) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

Accumulation Ratio Based on Cmax (Observed) (Rac,Cmax) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 2

Apparent Clearance (CL/F) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

+14 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: Dose Finding Endocrine Therapy 2 CombinationExperimental Treatment2 Interventions

Part 1B PF-06873600 plus Endocrine Therapy 2

Group II: Dose Finding Endocrine Therapy 1 CombinationExperimental Treatment2 Interventions

Part 1B PF-06873600 plus Endocrine Therapy 1

Group III: Dose Expansion Arm EExperimental Treatment2 Interventions

PF-06873600 in Combination with Endocrine Therapy 2

Group IV: Dose Expansion Arm DExperimental Treatment2 Interventions

PF-06873600 in Combination with Endocrine Therapy 1

Group V: Dose Expansion Arm CExperimental Treatment2 Interventions

PF-06873600 in Combination with Endocrine Therapy 1

Group VI: Dose Expansion Arm BExperimental Treatment1 Intervention

PF-06873600 as a Single Agent in Various Tumor Types

Group VII: Dose Expansion Arm AExperimental Treatment1 Intervention

PF-06873600 as a Single Agent

Group VIII: Dose EscalationExperimental Treatment1 Intervention

Single Agent Dose Escalation

0 / 13Eligibility 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 hormone therapies and targeted therapies. Hormone therapies like letrozole and fulvestrant are used for hormone receptor-positive (HR+) breast cancer. Letrozole inhibits aromatase, reducing estrogen production and slowing cancer growth. Fulvestrant degrades estrogen receptors, limiting the cancer cells' ability to use estrogen. Targeted therapies focus on specific molecular targets, such as HER2 inhibitors for HER2-positive breast cancer. Understanding these mechanisms helps personalize treatment, improving effectiveness and reducing side effects.

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