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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
Postmenopausal as defined by specific criteria or premenopausal/perimenopausal women amenable to LHRH agonist treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing whether a combination of two drugs is safe and effective for treating breast cancer in postmenopausal women.

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.Check my eligibility
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.See study design
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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I am postmenopausal or can receive hormone therapy if not.
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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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I stopped my first chemotherapy 21 days ago and it worked. I may have had chemo before for early cancer treatment.
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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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I have had hormone therapy for my cancer before surgery or as an additional treatment.
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My organs and bone marrow are functioning normally.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
Response rate

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979
91%
White blood cell count decreased
87%
Neutrophil count decreased
87%
Hypertension
83%
Fatigue
76%
Anemia
72%
Lymphocyte count decreased
57%
Nausea
54%
Back pain
52%
Diarrhea
52%
Hot flashes
44%
Headache
44%
Arthralgia
43%
Cough
43%
Alopecia
41%
Anorexia
41%
Dizziness
39%
Insomnia
35%
Hypercalcemia
35%
Pain
33%
Creatinine increased
33%
Platelet count decreased
31%
Dyspnea
31%
Edema limbs
31%
Hyponatremia
31%
Constipation
30%
Hyperkalemia
30%
Aspartate aminotransferase increased
28%
Peripheral sensory neuropathy
28%
Alkaline phosphatase increased
28%
Vomiting
28%
Alanine aminotransferase increased
28%
Hypocalcemia
28%
Depression
26%
Mucositis oral
26%
Anxiety
24%
Dyspepsia
22%
Chills
22%
Rash maculopapular
20%
Dysgeusia
20%
Hyperglycemia
19%
Sinusitis
19%
Dry skin
17%
Allergic rhinitis
17%
Hypokalemia
17%
Sore throat
17%
Myalgia
17%
Fall
15%
Hypoalbuminemia
15%
Upper respiratory infection
13%
Fever
13%
Hyperhidrosis
11%
Epistaxis
11%
Urinary tract infection
11%
Breast pain
11%
Bone pain
11%
Arthritis
11%
Lymphedema
9%
Skin infection
9%
Knee pain
9%
Hypernatremia
9%
Pain in extremity
9%
Pleural effusion
9%
Nasal congestion
9%
Dysphagia
9%
Gastroesophageal reflux disease
7%
Hypophosphatemia
7%
Itchy skin
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Thromboembolic event
6%
Blurred vision
6%
Respiratory syncytial virus (RSV)
6%
Vertigo
6%
Red eye
6%
Non-cardiac chest pain
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Bronchitis
6%
Lung infection
6%
Sacroliac joint pain
6%
Shoulder pain
6%
Osteopenia
6%
Rash acneiform
6%
Leg stiffness
6%
Gout
6%
Weight loss
6%
Blister
4%
Dry eye
4%
Right arm numbness
4%
Nodule
4%
Watering eyes
4%
Edema trunk
4%
Flu-like symptoms
4%
Vaginal dryness
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Sinus pain
4%
Hemoglobin increased
4%
Dry mouth
4%
Tick bite
4%
Allergic reaction
4%
Extremity infection
4%
Hypoglycemia
4%
Generalized muscle weakness
4%
Sleep apnea
4%
Right thumb bump
4%
Urinary frequency
4%
Chest pain - cardiac
4%
Muscle cramp
4%
Muscle spasm
4%
Bruising
4%
Bug bite
4%
Burn - left hand
4%
Brittle nail
2%
Gait disturbance
2%
Peeling lips
2%
Cataract
2%
Paresthesia
2%
Vaginal itch
2%
Photophobia
2%
Facial nerve disorder
2%
Erythema right breast
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Radiation recall reaction (dermatologic)
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Erythema multiforme
2%
Peeling skin palms of hands
2%
Urinary retention
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Tooth infection
2%
Laryngeal inflammation
2%
Activated partial thromboplastin time prolonged
2%
Abdominal pain
2%
Fracture
2%
Urine discoloration
2%
Asthma
2%
Hoarseness
2%
Wrist fracture
2%
Hand cramps
2%
C. difficile
2%
Hemorrhoids
2%
Pharyngitis
2%
Left hand puncture wound
2%
Vaginal discharge
2%
Nail loss
2%
Oral fissure
2%
Superficial thrombophlebitis
2%
Dry lips
2%
Paronychia - infection right middle
2%
Snake bite
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Toothache
2%
Ulcerative colitis
2%
Acute bronchitis
2%
COVID-19
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Hypomagnesemia
2%
Bilateral leg pain
2%
Chest wall pain
2%
Flank pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Rhinovirus
2%
Voice alteration
2%
Cellulitis
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Osteonecrosis of jaw
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Acute kidney injury
2%
Asystole
2%
Generalized weakness
2%
Sepsis
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Eye lid pain
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
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
~3720

Find a Location

Who is running the clinical trial?

Antoinette Tan, MDLead Sponsor
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Breast Cancer
Atrium Health Levine Cancer InstituteOTHER
13 Previous Clinical Trials
1,236 Total Patients Enrolled
2 Trials studying Breast Cancer
296 Patients Enrolled for Breast Cancer
Wake Forest University Health SciencesLead Sponsor
1,231 Previous Clinical Trials
1,001,773 Total Patients Enrolled
32 Trials studying Breast Cancer
5,020 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02942355 — Phase 2
Breast Cancer Research Study Groups: Cohort A: First-line therapy, Cohort B: Maintenance therapy
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT02942355 — Phase 2
Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02942355 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Palbociclib been tested in prior medical studies?

"As of now, 191 trials using Palbociclib are currently running worldwide. Of these studies 36 have entered the final phase 3 stage. The majority of clinical sites utilizing this treatment can be found in Burgas, New jersey; however, a total of 13528 trial locations exist around the globe."

Answered by AI

What is the principal application of Palbociclib?

"Palbociclib can be applied to manage breast cancer, as well as other malignant neoplasms with hormone receptor unknown and in cases where 2-3 years of tamoxifen therapy have failed."

Answered by AI

What is the current enrollment cap for this medical research?

"Unfortunately, this trial has already stopped taking applications. First posted in October 2016 and last revised on June 2022, it is now closed to new enrolment. However, there are still 2282 studies actively recruiting for breast cancer and 191 trials looking for participants that can take Palbociclib."

Answered by AI

Is enrollment still open for this clinical research?

"This clinical trial is not currently recruiting patients. It was posted on October 26, 2016 and last updated June 23, 2022. If you are interested in alternative studies, there are 2282 active breast cancer trials and 191 Palbociclib-related investigations searching for participants."

Answered by AI

Do the potential benefits of Palbociclib outweigh any possible risks?

"Although there have been some examinations into palbociclib's safety, efficacy data is still absent. Thus, our team at Power gave it a rating of 2 on the 1-3 scale."

Answered by AI
~9 spots leftby Jun 2026