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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start date to date of progression/death, or censored as described; assessed for approximately 4 years.
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 belowSelect...
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.
Select...
My latest tumor biopsy shows I do not have HER2-positive cancer.
Select...
I have not received treatment for metastatic disease in Cohort A.
Select...
My cancer can be measured by scans or is only in my bones.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My breast cancer is advanced and cannot be removed with surgery.
Select...
I can provide samples of my tumor, either from previous or new biopsies.
Select...
My organs and bone marrow are functioning normally.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
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 moreSide effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
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%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
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%
Upper respiratory infection
17%
Sinusitis
17%
Peripheral sensory neuropathy
17%
Fever
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
9%
Hypophosphatemia
9%
Epistaxis
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Death
6%
Cataract
6%
Dehydration
6%
Knee pain
6%
Itchy skin
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Back spasms
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Burn
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Sinus pain
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Intrascapular pain
2%
Hemorrhoids
2%
Pharyngitis
2%
Activated partial thromboplastin time prolonged
2%
Erythema right breast
2%
Sinus tachycardia
2%
Puncture wound
2%
Hypermagnesemia
2%
Vaginal discharge
2%
Leg pain
2%
Wrist fracture
2%
Erythema multiforme
2%
Cold sweats
2%
Paronychia
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Facial nerve disorder
2%
Paresthesia
2%
Urinary retention
2%
Hyperuricemia
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
COPD
2%
Fracture
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
2%
Lung cancer
2%
Vaginal itching
2%
Radiation recall reaction (dermatologic)
2%
Bilateral nares sores
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
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%
Blister
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
~3760
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
18 Previous Clinical Trials
1,494 Total Patients Enrolled
3 Trials studying Breast Cancer
303 Patients Enrolled for Breast Cancer
Wake Forest University Health SciencesLead Sponsor
1,244 Previous Clinical Trials
1,004,748 Total Patients Enrolled
34 Trials studying Breast Cancer
5,047 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active brain metastases or related conditions.You are allergic to anastrozole.I am not taking any strong medications that affect liver enzymes.I haven't had major surgery or cancer treatment in the last 3 weeks.I am HIV positive.I have had a bone marrow or stem cell transplant.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I do not have any severe health or mental conditions that could make this study risky for me.My cancer can be measured by scans or is only in my bones.I have not received treatment for metastatic disease in Cohort A.I stopped my first chemotherapy 21 days ago and it worked. I may have had chemo before for early cancer treatment.I am postmenopausal or can receive hormone therapy if not.My most recent tumor biopsy shows that my cancer is ER or PR positive.My latest tumor biopsy shows I do not have HER2-positive cancer.My breast cancer is advanced and cannot be removed with surgery.I can provide samples of my tumor, either from previous or new biopsies.I have been treated with a CDK inhibitor before.I haven't had heart, brain, or lung problems in the last 6 months.I have had hormone therapy for my cancer before surgery or as an additional treatment.My stomach or intestines do not work well, affecting how I absorb medication.My organs and bone marrow are functioning normally.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: First-line therapy
- Group 2: Cohort B: Maintenance therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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