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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
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.
Men and pre- and postmenopausal women are eligible. Ongoing monthly GNRH agonist is required in pre-menopausal women or male participants for at least 4 weeks prior to study entry.
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
No Placebo-Only Group

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 below
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My breast cancer is hormone receptor positive and HER2 negative, and cannot be surgically removed.
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I am a man or a woman (pre- or postmenopausal) and if premenopausal, I have been on a GNRH agonist for 4 weeks.
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My cancer progressed after treatment with endocrine therapy and CDK 4/6 inhibitors.
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I have been treated with CDK4/6 inhibitors and hormone therapy for my cancer.
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I have been on hormone and CDK4/6 therapy for my cancer for at least 6 months without it getting worse.
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I have had at most one chemotherapy treatment for my cancer after it spread.
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I have had 1-2 prior hormone treatments for my cancer, but not fulvestrant.
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I had radiotherapy for comfort care over 2 weeks ago and have mild or no side effects.
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I am 18 years old or older.
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I can carry out all my usual activities without help.
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My organ and bone marrow functions are normal.
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My kidney function, measured by creatinine levels, is normal or nearly normal.
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I agree to use birth control during and for 60 days after the study if there's a risk of pregnancy.
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I am using reliable birth control methods to prevent pregnancy.
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I am premenopausal and have a negative pregnancy test.
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I can swallow and keep down pills.

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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and the median follow-up time for adverse event was 5.4 months (range 1.6 months to 51.2 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
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 • 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%
Arthralgia
44%
Headache
43%
Cough
43%
Alopecia
41%
Anorexia
41%
Dizziness
39%
Insomnia
35%
Pain
35%
Hypercalcemia
33%
Creatinine increased
33%
Platelet count decreased
31%
Hyponatremia
31%
Dyspnea
31%
Constipation
31%
Edema limbs
30%
Hyperkalemia
30%
Aspartate aminotransferase increased
28%
Alkaline phosphatase increased
28%
Vomiting
28%
Alanine aminotransferase increased
28%
Hypocalcemia
28%
Depression
28%
Peripheral sensory neuropathy
26%
Mucositis oral
26%
Anxiety
24%
Dyspepsia
22%
Chills
22%
Rash maculopapular
20%
Hyperglycemia
20%
Dysgeusia
19%
Sinusitis
19%
Dry skin
17%
Hypokalemia
17%
Sore throat
17%
Myalgia
17%
Fall
17%
Allergic rhinitis
15%
Upper respiratory infection
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Fever
11%
Epistaxis
11%
Urinary tract infection
11%
Breast pain
11%
Bone pain
11%
Arthritis
11%
Lymphedema
9%
Knee pain
9%
Hypernatremia
9%
Skin infection
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%
Non-cardiac chest pain
6%
Respiratory syncytial virus (RSV)
6%
Blurred vision
6%
Psoriasis
6%
Red eye
6%
Body aches
6%
Buttock pain
6%
Bronchitis
6%
Lung infection
6%
Sacroliac joint pain
6%
Shoulder pain
6%
Vertigo
6%
Osteopenia
6%
Rash acneiform
6%
Leg stiffness
6%
Gout
6%
Weight loss
6%
Blister
4%
Hypothyroidism
4%
Dry eye
4%
Hip pain
4%
Broken tooth
4%
Right arm numbness
4%
Nodule
4%
Flu-like symptoms
4%
Watering eyes
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%
Edema trunk
4%
Bruising
4%
Bug bite
4%
Burn - left hand
4%
Peripheral motor neuropathy
4%
Sinus pain
4%
Vaginal dryness
4%
Brittle nail
2%
Hoarseness
2%
Oral fissure
2%
Peeling lips
2%
Radiation recall reaction (dermatologic)
2%
Nail loss
2%
Gait disturbance
2%
C. difficile
2%
Photophobia
2%
Left hand puncture wound
2%
Peeling skin palms of hands
2%
Abdominal pain
2%
Tooth infection
2%
Open cutaneous area left breast
2%
Mole pain
2%
Itchy scalp
2%
Fracture
2%
Hand cramps
2%
Laryngeal inflammation
2%
Eye lid pain/soreness
2%
Cataract
2%
Pharyngitis
2%
Head injury - upper left occipital swelling
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%
Spinal fracture
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
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%
Hemorrhoids
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Acoustic neuroma
2%
Facial nerve disorder
2%
Paresthesia
2%
Spasticity
2%
Syncope
2%
Urinary retention
2%
Urine discoloration
2%
Vaginal discharge
2%
Vaginal itch
2%
Asthma
2%
Erythema multiforme
2%
Erythema right breast
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3720
Avelumab
2018
Completed Phase 2
~2450
Fulvestrant
2011
Completed Phase 3
~3700

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,066 Previous Clinical Trials
338,805 Total Patients Enrolled
140 Trials studying Breast Cancer
21,571 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,542 Previous Clinical Trials
10,145,087 Total Patients Enrolled
110 Trials studying Breast Cancer
33,604 Patients Enrolled for Breast Cancer
Erica L Mayer, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03147287 — Phase 2
Breast Cancer Research Study Groups: Fulvestrant, Fulvestrant with Palbociclib, Fulvestrant with Palbociclib and Avelumab
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT03147287 — Phase 2
Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03147287 — Phase 2

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
~30 spots leftby Feb 2025