Your session is about to expire
← Back to Search
Estrogen Receptor Antagonist
Palbociclib + Hormone Therapy for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side effects and effectiveness of two drugs, palbociclib and letrozole or fulvestrant, in treating older patients with breast cancer.
Who is the study for?
This trial is for patients aged 70+ with estrogen receptor positive, HER2 negative metastatic breast cancer. They must have adequate organ function, no active infections or recent malignancies (except certain skin cancers), and be able to understand English or Spanish. Prior treatment with CDK inhibitors disqualifies them, as does untreated brain metastases or known lung disease.Check my eligibility
What is being tested?
The study tests the effectiveness of palbociclib combined with letrozole or fulvestrant in older adults with advanced breast cancer. It examines how well these drugs stop tumor growth by blocking enzymes needed for cell division and spread, considering factors beyond age that may affect drug toxicity.See study design
What are the potential side effects?
Palbociclib can cause low blood cell counts leading to increased infection risk and fatigue; letrozole and fulvestrant might cause hot flashes, joint pain, weakness, nausea. The combination could potentially increase these effects but aims to better control cancer growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is estrogen or progesterone positive and HER2 negative.
Select...
I have treated brain metastases and am not currently on steroids.
Select...
I do not have any infections that need antibiotics.
Select...
I can swallow and keep down pills.
Select...
My kidneys are functioning well enough for treatment.
Select...
I have never been treated with a CDK inhibitor.
Select...
I do not have interstitial lung disease.
Select...
I can care for myself and am up and about more than 50% of my waking hours.
Select...
I can read and understand English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Secondary outcome measures
Dose Reduction, Dose Hold, and Hospitalization Reasons
Incidence of Drug Toxicities - Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0
Overall Survival (OS)
+7 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%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
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%
Tooth infection
7%
Non-cardiac chest pain
7%
Skin infection
7%
Blurred vision
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Death
6%
Cellulitis
6%
Cataract
6%
Itchy skin
6%
Dehydration
6%
Knee pain
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%
Vaginal dryness
4%
Watering eyes
4%
Burn
4%
Flu-like symptoms
4%
Edema trunk
4%
Back spasms
4%
Dry eye
4%
Sinus pain
4%
Head injury
4%
Memory impairment
4%
Skin bump
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%
Bilateral nares sores
2%
Puncture wound
2%
Paronychia
2%
Intrascapular pain
2%
Vaginal infection
2%
Hoarseness
2%
COPD
2%
Sinus congestion
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Yeast infection
2%
Hyperuricemia
2%
Facial nerve disorder
2%
Paresthesia
2%
Agitation
2%
Urinary retention
2%
Oral fissure
2%
Eye lid pain
2%
Pharyngitis
2%
Blood bilirubin increased
2%
Flank pain
2%
Cognitive disturbance
2%
Radiation recall reaction (dermatologic)
2%
Photophobia
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Hemorrhoids
2%
Cold sweats
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Wrist pain
2%
Leg pain
2%
Localized edema
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Hypermagnesemia
2%
Lung cancer
2%
Urine discoloration
2%
Vaginal discharge
2%
Laryngeal inflammation
2%
Erythema multiforme
2%
Erythema right breast
2%
Nail loss
2%
Shoulder nodule
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
1Treatment groups
Experimental Treatment
Group I: Treatment (palbociclib, letrozole or fulvestrant)Experimental Treatment5 Interventions
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Letrozole
FDA approved
Fulvestrant
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,060 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,545 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
Mina Sedrak, MD, MSStudy ChairCity of Hope Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no active cancer other than non-melanoma skin cancer or cervical carcinoma in situ, or I have been free of any other cancer for 3 years.Your body has enough infection-fighting white blood cells.My breast cancer is estrogen or progesterone positive and HER2 negative.I have recovered from side effects of previous treatments, except for hair loss.My cancer can be measured by tests or seen on scans.Your liver enzymes (AST and ALT) are not too high, unless you have cancer that has spread to your liver.Your alkaline phosphatase levels are not too high, unless you have bone or liver metastases.I have treated brain metastases and am not currently on steroids.I do not have any infections that need antibiotics.I can swallow and keep down pills.My kidneys are functioning well enough for treatment.I have never been treated with a CDK inhibitor.I do not have interstitial lung disease.I can care for myself and am up and about more than 50% of my waking hours.I am starting palbociclib for my metastatic disease and may have had one prior treatment.Your platelet count is at least 100,000 per mm^3.I can read and understand English or Spanish.Your bilirubin level in your blood is within a certain range, unless you have a specific condition called Gilbert's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (palbociclib, letrozole or fulvestrant)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
What objectives are being targeted via this clinical trial?
"The primary endpoint of this research trial, which will span up to one year, is the incidence of adverse effects. Secondary aims include evaluating progression-free survival (PFS) using Kaplan-Meier methodology, quantifying patients' quality of life with the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L), and estimating overall survival times with Kaplan Meier methodology."
Answered by AI
How many venues are managing this investigation?
"This research effort is currently recruiting from a grand total of 100 sites, some of which are based in Delaware, Hibbing and Westerville. For the convenience of potential participants, it's advised to select the trial centre closest to them so they can avoid lengthy journeys during the study."
Answered by AI
Have any prior experiments studied the effects of Palbociclib?
"Currently, a total of 334 clinical trials are running for Palbociclib. Of those studies, 68 have reached the third phase of trialling and 18656 sites across Shanghai offer treatments with this drug."
Answered by AI
How many individuals are being enrolled in this medical trial?
"Unfortunately, this clinical trial is currently closed to new participants. It was initially listed on August 15th 2018 and last updated September 17th 2021. If you are looking for similar studies, 2288 trials searching for patients with HER2/neu negative status and 334 Palbociclib trails are actively seeking volunteers."
Answered by AI
Is this investigation currently recruiting participants?
"This trial is no longer recruiting participants. It began on August 15th 2018 and was most recently edited September 17th 2021. However, if you are searching for other studies, there are 2288 trials actively looking to recruit patients with her2/neu negative issues, as well as 334 trials that involve Palbociclib medications which have openings for enrolment."
Answered by AI
For which ailments is Palbociclib typically prescribed?
"Palbociclib has been demonstrated to effectively treat progression, disease, tamoxifen and postmenopausal symptoms."
Answered by AI
Does the FDA allow Palbociclib to be utilized in clinical practice?
"Though not yet proven efficacious, Palbociclib has been evaluated as having some level of safety and was thus assigned a score of 2."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger