What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as aromatase inhibitors (e.g., anastrozole) and CDK4/6 inhibitors (e.g., palbociclib), have distinct side effect profiles. Aromatase inhibitors can lead to loss of bone density, increased risk of fractures, and cardiovascular issues. CDK4/6 inhibitors are often associated with neutropenia (low white blood cell count), fatigue, nausea, and diarrhea. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for hormone receptor-positive, HER2-negative breast cancer that are similar to the combination of anastrozole and palbociclib. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, reduce estrogen production, which is essential for the growth of some breast cancers. CDK4/6 inhibitors, including palbociclib, ribociclib, and abemaciclib, prevent cancer cell proliferation by inhibiting cyclin-dependent kinases 4 and 6. These drugs are often used in combination to improve treatment outcomes in postmenopausal women with advanced or metastatic breast cancer.

What other types of research exist?

Promising alternatives to Anastrozole and Palbociclib for breast cancer treatment include Abemaciclib and Ribociclib, which are also CDK4/6 inhibitors. Additionally, Fulvestrant, a selective estrogen receptor degrader (SERD), can be used in combination with these inhibitors. Emerging therapies such as Alpelisib, a PI3K inhibitor, for patients with PIK3CA-mutated breast cancer, and novel SERDs like Elacestrant, are also showing potential in clinical trials.

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Hormone Therapy

Anastrozole + Palbociclib for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Antoinette Tan, MD

Eligibility Criteria Checklist

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

Must have

Patients must be 18 years of age or older

Documentation of ER-positive and/or PR-positive tumor based on most recent tumor biopsy (unless bone-only disease)

Must not have

Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease

Use of specific food or drugs known to be potent CYP3A4 inhibitors and inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to best response while on study treatment; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. assessed for approximately 4 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and feasibility of using two drugs, anastrozole and palbociclib, together. It targets postmenopausal women with a specific type of breast cancer that may not respond well to other treatments. The treatment works by lowering estrogen levels and stopping cancer cells from growing. Anastrozole is used to significantly reduce plasma estrogen levels in postmenopausal women with advanced breast cancer.

Who is the study for?

This trial is for postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. It's open to those who haven't had treatment for metastatic disease (Cohort A) or as maintenance after first-line chemo (Cohort B). Participants need measurable disease, good performance status, and normal organ function. Pre/peri-menopausal women must be on LHRH agonist therapy.

What is being tested?

The study tests combining anastrozole with palbociclib in two groups: one receiving it as a first-line therapy and the other as maintenance post-chemo. It's an open-label pilot study where patients are assigned to either Cohort A or B based on their treatment history.

What are the potential side effects?

Possible side effects include fatigue, nausea, blood count changes leading to increased infection risk, liver issues, hair thinning or loss, neuropathy (nerve problems), and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My most recent tumor biopsy shows that my cancer is ER or PR positive.

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My latest tumor biopsy shows I do not have HER2-positive cancer.

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I have not received treatment for metastatic disease in Cohort A.

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My cancer can be measured by scans or is only in my bones.

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I can take care of myself and am up and about more than half of my waking hours.

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My breast cancer is advanced and cannot be removed with surgery.

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I can provide samples of my tumor, either from previous or new biopsies.

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My organs and bone marrow are functioning normally.

Exclusion Criteria

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

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I do not have active brain metastases or related conditions.

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I am not taking any strong medications that affect liver enzymes.

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I haven't had major surgery or cancer treatment in the last 3 weeks.

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I am HIV positive.

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I have had a bone marrow or stem cell transplant.

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I have been treated with a CDK inhibitor before.

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My stomach or intestines do not work well, affecting how I absorb medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to treatment discontinuation; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. assessed for approximately 4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to treatment discontinuation; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. assessed for approximately 4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to treatment discontinuation; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. assessed for approximately 4 years. 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 neutropenia that leads to permanent treatment discontinuation

Secondary study objectives

Number of participants with an objective response

Number of participants with clinical benefit

Overall Survival (OS)

+1 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

73%

Palmar-plantar erythrodysesthesia syndrome

58%

Fatigue

56%

Diarrhea

38%

Hypertension

38%

Nausea

30%

Mucositis

29%

Vomiting

26%

Weight loss

26%

Weight gain

24%

Anorexia

20%

Nail disorder

17%

Back pain

16%

Hypothermia

15%

Constipation

15%

Abdominal pain

14%

Neutrophil count decreased

13%

Upper respiratory infection

13%

Headache

13%

Dizziness

11%

Dyspepsia

10%

Pain in extremity

10%

Fever

10%

Obesity

10%

Dysgeusia

Arthralgia

Bone pain

Anemia

Cough

Pruritus

Flu like symptoms

Pain

Alopecia

Thromboembolic event

Bone fracture

Febrile neutropenia

Respiratory infection

Pancreatitis

Hot flashes

Spinal cord compression

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Cohort 2: Palbociclib Plus Fulvestrant

Awards & Highlights

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: Cohort B: Maintenance therapyExperimental Treatment2 Interventions

Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle

Group II: Cohort A: First-line therapyExperimental Treatment2 Interventions

Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

anastrozole

2005

Completed Phase 3

~18970

Palbociclib

2017

Completed Phase 3

~3880

0 / 16Eligibility 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

Aromatase inhibitors, such as anastrozole, reduce estrogen production, which is crucial for slowing the growth of hormone receptor-positive breast cancer cells. CDK4/6 inhibitors, like palbociclib, prevent cancer cell proliferation by inhibiting cyclin-dependent kinases 4 and 6, essential for cell cycle progression. These mechanisms are important for breast cancer patients as they help in selecting targeted therapies that can effectively slow down or stop cancer cell growth, leading to better outcomes and personalized treatment plans.

Abemaciclib, a CDK4 and CDK6 inhibitor for the treatment of metastatic breast cancer.Time to treatment failure of palbociclib and letrozole as second-line therapy or beyond in hormone receptor-positive advanced breast cancer.