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Hormone Therapy
Combination Therapy for Breast Cancer
Phase 2
Waitlist Available
Led By Erica L Mayer, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine < institutional ULN or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional ULN.
Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative metastatic or locally recurrent unresectable invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the median follow-up time for adverse event was 5.4 months (range 1.6 months to 51.2 months).
Awards & highlights
Study Summary
This trial is testing if any of these combinations can help treat breast cancer.
Who is the study for?
This trial is for adults with hormone receptor positive, HER2 negative breast cancer that has worsened on or after CDK4/6 inhibitor therapy. Participants must have good performance status, normal organ and marrow function, and no prior fulvestrant treatment in the metastatic setting. Pregnant women are excluded, and effective contraception is required.Check my eligibility
What is being tested?
The study tests three drug combinations for breast cancer: Fulvestrant alone; Fulvestrant with Palbociclib; and Fulvestrant with both Palbociclib and Avelumab. It aims to find out which combination works best for patients who've seen their disease progress after previous treatments.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, blood count changes (which can increase infection risk), liver enzyme alterations suggesting liver stress, potential heart rhythm issues from QTc prolongation, allergic reactions to drugs used in the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels, is normal or nearly normal.
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My breast cancer is hormone receptor positive and HER2 negative, and cannot be surgically removed.
Select...
I have been on hormone and CDK4/6 therapy for my cancer for at least 6 months without it getting worse.
Select...
I am 18 years old or older.
Select...
I can swallow and keep down pills.
Select...
My cancer progressed after treatment with endocrine therapy and CDK 4/6 inhibitors.
Select...
I can carry out all my usual activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the median follow-up time for adverse event was 5.4 months (range 1.6 months to 51.2 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the median follow-up time for adverse event was 5.4 months (range 1.6 months to 51.2 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability)
Overall Response Rate, According to RECIST v1.1 Criteria (Investigator Assessment)
Side 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Fulvestrant with Palbociclib and AvelumabExperimental Treatment3 Interventions
Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye
Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly
Avelumab will be administered intravebously once every 2 weeks
Group II: Fulvestrant with PalbociclibExperimental Treatment2 Interventions
Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye
Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly
Group III: FulvestrantActive Control1 Intervention
-Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Avelumab
2018
Completed Phase 2
~2450
Fulvestrant
2011
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
341,013 Total Patients Enrolled
142 Trials studying Breast Cancer
22,617 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,575 Previous Clinical Trials
10,922,881 Total Patients Enrolled
112 Trials studying Breast Cancer
35,865 Patients Enrolled for Breast Cancer
Erica L Mayer, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious allergic reaction to the study drug or any of its ingredients in the past.I am not taking any medications that affect my heart's rhythm.You have a current hepatitis B or hepatitis C virus infection.I had cancer before, but it's been 3 years and it was not likely to come back, or it was a minor skin, breast, or cervical cancer treated within the last 5 years.I have not received a live vaccine within the last 4 weeks.I have an autoimmune disease but it's not severe and doesn't require immunosuppressive treatment.I am not pregnant and will not breastfeed if I join the study.Your liver enzymes should be within a certain range, unless you have cancer that has spread to your liver.I am HIV positive or have AIDS and may need antiretroviral therapy.I have a history of immune conditions like colitis or lung issues needing steroids.Your total bilirubin level should be below a certain limit, unless you have documented Gilbert's disease.I am using reliable birth control methods to prevent pregnancy.I haven't had cancer treatment in the last 14 days and have recovered from previous treatment side effects.I am allergic to palbociclib or similar medications.I am not on strong immune-suppressing drugs, except for low-dose steroids or certain topical forms.My cancer is spreading quickly and could soon lead to life-threatening issues.I stopped taking palbociclib due to side effects or needed to lower the dose more than once.I am a man or a woman (pre- or postmenopausal) and if premenopausal, I have been on a GNRH agonist for 4 weeks.My breast cancer is hormone receptor positive and HER2 negative, and cannot be surgically removed.I have been on hormone and CDK4/6 therapy for my cancer for at least 6 months without it getting worse.I am 18 years old or older.I do not have any serious ongoing illnesses that my doctor thinks could interfere with the study.I have been treated with CDK4/6 inhibitors and hormone therapy for my cancer.I have had at most one chemotherapy treatment for my cancer after it spread.I have had 1-2 prior hormone treatments for my cancer, but not fulvestrant.I had radiotherapy for comfort care over 2 weeks ago and have mild or no side effects.My kidney function, measured by creatinine levels, is normal or nearly normal.I agree to use birth control during and for 60 days after the study if there's a risk of pregnancy.I can swallow and keep down pills.My cancer progressed after treatment with endocrine therapy and CDK 4/6 inhibitors.I can carry out all my usual activities without help.I have brain metastases but they are stable and I don't need steroids for symptoms.Your heart's electrical activity (QTc) is less than 480 milliseconds when measured before starting the study.My organ and bone marrow functions are normal.Your white blood cell count is too low.I have had an organ or stem-cell transplant.I am not taking any strong medication that affects liver enzymes.Your hemoglobin level is higher than 9 grams per deciliter.I am premenopausal and have a negative pregnancy test.You have a platelet count higher than 100,000 per microliter.
Research Study Groups:
This trial has the following groups:- Group 1: Fulvestrant
- Group 2: Fulvestrant with Palbociclib
- Group 3: Fulvestrant with Palbociclib and Avelumab
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.
What conditions are commonly addressed through the use of Palbociclib?
"Palbociclib is used to manage progression of illness, ameliorate disease symptoms, implement advance directives, and treat postmenopausal issues."
Answered by AI
Is this clinical trial currently enrolling participants?
"Looking at clinicaltrials.gov, the data suggests that this trial is not presently accepting patients. Having been initially published on August 9th 2017 and last changed on September 19th 2022, it appears as though there are currently no openings for this study; however, 2639 other medical trials are actively enrolling individuals."
Answered by AI
Are there any Canadian healthcare facilities administering this trial?
"The University of Kansas Cancer Center - Lee's Summit in Lee's Summit, Missouri, Indiana University in Indianapolis, Indiana and Vanderbilt University Medical Center in Nashville, Tennessee are the primary medical facilities hosting this clinical trial. Additionally 22 other sites have been identified to assist with enrolment."
Answered by AI
Could you please provide information on previous trials that have incorporated Palbociclib?
"The first clinical trial of palbociclib was held at Lowell General Hospital in 2004 and has since been studied 201 times. Presently, 342 trials are actively being conducted, with the majority taking place near Lee's Summit, Missouri."
Answered by AI
Has Palbociclib been granted regulatory acceptance by the Food and Drug Administration?
"Palbociclib has been assigned a risk score of 2 due to its status as a Phase 2 trial. This rating denotes that there is some evidence pointing towards the drug's safety, but no data supporting efficacy yet."
Answered by AI
What is the estimated sample size for this research endeavor?
"This medical trial is currently not accepting participants. It was initially published on August 9, 2017 and most recently revised on September 19, 2022. For those who are interested in other studies, there are presently 2297 clinical trials actively recruiting for malignant neoplasms and 342 trials involving Palbociclib that require volunteers."
Answered by AI
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