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

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

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

Primary outcome measures

Number of participants with neutropenia that leads to permanent treatment discontinuation

Secondary outcome measures

Number of participants with an objective response

Number of participants with clinical benefit

Overall Survival (OS)

+1 more

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979

96%

White blood cell count decreased

87%

Neutrophil count decreased

80%

Anemia

74%

Lymphocyte count decreased

67%

Hypertension

61%

Fatigue

56%

Diarrhea

54%

Nausea

43%

Platelet count decreased

41%

Alopecia

39%

Headache

39%

Hot flashes

37%

Dizziness

37%

Insomnia

37%

Dyspepsia

35%

Hyponatremia

35%

Arthralgia

35%

Anorexia

35%

Cough

35%

Aspartate aminotransferase increased

33%

Edema limbs

33%

Alanine aminotransferase increased

33%

Creatinine increased

31%

Hypercalcemia

31%

Hyperkalemia

31%

Mucositis oral

31%

Vomiting

31%

Hypocalcemia

30%

Dyspnea

30%

Alkaline phosphatase increased

30%

Back pain

28%

Constipation

26%

Pain

26%

Hypokalemia

24%

Chills

20%

Hyperglycemia

20%

Dysgeusia

20%

Depression

20%

Myalgia

20%

Fall

19%

Pain in extremity

19%

Rash maculopapular

17%

Peripheral sensory neuropathy

17%

Fever

17%

Sinusitis

17%

Upper respiratory infection

17%

Anxiety

17%

Sore throat

15%

Hypoalbuminemia

13%

Urinary tract infection

13%

Hyperhidrosis

13%

Bone pain

13%

Nasal congestion

13%

Dry skin

11%

Hypernatremia

11%

Allergic rhinitis

11%

Weight loss

Hypophosphatemia

Epistaxis

COVID-19

Dysphagia

Vertigo

Blurred vision

Non-cardiac chest pain

Skin infection

Tooth infection

Breast pain

Bronchitis

Postnasal drip

Common cold

Neck pain

Lymphedema

Itchy skin

Dehydration

Knee pain

Psoriasis

Death

Cellulitis

Cataract

Body aches

Buttock pain

Lung infection

Allergic reaction

Hypoglycemia

Urinary frequency

Osteopenia

Rash acneiform

Gout

Bug bite

Arthritis

Thromboembolic event

Watering eyes

Burn

Edema trunk

Flu-like symptoms

Back spasms

Memory impairment

Skin bump

Broken tooth

Dry eye

Abdominal pain

Head injury

Sinus pain

Vaginal dryness

Right arm numbness

Nodule

Hip pain

Peripheral motor neuropathy

Hypothyroidism

Dry lips

Toothache

Tick bite

Extremity infection

Hypomagnesemia

Generalized muscle weakness

Pleural effusion

Sleep apnea

Right thumb bump

Osteonecrosis of jaw

Chest pain - cardiac

Acute kidney injury

Muscle cramp

Muscle spasm

Gastroesophageal reflux disease

Bruising

Burn - left hand

Brittle nail

Photophobia

Leg pain

Pharyngitis

Rhinovirus

Radiation recall reaction (dermatologic)

Groin pain

Wrist pain

Bladder infection

Fungal toe infection

Paronychia

Gait disturbance

Agitation

Urinary retention

Nail loss

Oral fissure

Activated partial thromboplastin time prolonged

Urine discoloration

Vaginal discharge

Vaginal itching

Hemorrhoids

Blood bilirubin increased

Generalized weakness

Sepsis

Fracture

C. difficile

Puncture wound

Hypermagnesemia

Hyperuricemia

Flank pain

Intrascapular pain

Shoulder nodule

Red eye

Diverticulitis

Cognitive disturbance

Eye lid pain

Sinus tachycardia

Localized edema

Cold sweats

Respiratory syncytial virus (RSV)

Yeast infection

Wrist fracture

Lung cancer

Facial nerve disorder

Paresthesia

Peeling lips

Vaginal itch

Head injury - upper left occipital swelling

Acoustic neuroma

Eye lid pain/soreness

Open cutaneous area left breast

Peeling skin palms of hands

Mole pain

Itchy scalp

Spinal fracture

Asthma

Hand cramps

Left hand puncture wound

Myocardial infarction

Vaginal infection

Wound infection

COPD

Hoarseness

Laryngeal inflammation

Sinus congestion

Bilateral nares sores

Erythema multiforme

Erythema right breast

Fever blister

Superficial thrombophlebitis

Paronychia - infection right middle

Snake bite

Hemoglobin increased

Muscle weakness lower limb

Right arm pain

Mitral valve disease

Tinnitus

Vestibular schwannoma

Dry mouth

Oral dysesthesia

Oral pain

Stomach pain

Ulcerative colitis

Acute bronchitis

Otitis media

INR increased

Lymphocyte count increased

Bilateral leg pain

Chest wall pain

Left sided flank pain

Sternum pain

ADHD

Confusion

Sacroliac joint pain

Shoulder pain

Hallucinations

Mood swings

Nasal dryness

Productive cough

Voice alteration

Hypotension

Cold sensitivity

Sciatic pain

Nasal drainage

Heart failure

Skin bumps

Skin hypopigmentation

Leg stiffness

Asystole

Failure to thrive

Intracranial hemorrhage

Gastric ulcer

Gingival pain

Hematochezia

Hemorrhoidal hemorrhage

Dilation of appendix with periappendiceal fat stranding seen on CT

Edema face

Yeast infection under right breast

Weight gain

Spasticity

Syncope

Blister

Sores bilateral nares

Stomach rash

Tender nail bed

100%

80%

60%

40%

20%

Study treatment Arm

Palbociclib + Letrozole or + Fulvestrant

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

~3760

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.