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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.
Must not have
Current use of drugs listed in Appendix C that are known to prolong the QT interval (See Appendix C)
Pregnant women are excluded from this study because effect of palbociclib and avelumab on a developing fetus is unknown. Breastfeeding should be discontinued prior to entry onto the study.
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

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 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.
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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 am 18 years old or older.
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I can swallow and keep down pills.
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My cancer progressed after treatment with endocrine therapy and CDK 4/6 inhibitors.
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I can carry out all my usual activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that affect my heart's rhythm.
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I am not pregnant and will not breastfeed if I join the study.
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I am HIV positive or have AIDS and may need antiretroviral therapy.
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I have a history of immune conditions like colitis or lung issues needing steroids.
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I am allergic to palbociclib or similar medications.
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My cancer is spreading quickly and could soon lead to life-threatening issues.
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I have had an organ or stem-cell transplant.
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I am not taking any strong medication that affects liver enzymes.

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
96%
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%
Cough
35%
Anorexia
35%
Hyponatremia
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hypercalcemia
31%
Hyperkalemia
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%
Sinusitis
17%
Upper respiratory infection
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%
Non-cardiac chest pain
7%
Blurred vision
7%
Tooth infection
7%
Skin infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Itchy skin
6%
Psoriasis
6%
Cataract
6%
Death
6%
Cellulitis
6%
Dehydration
6%
Knee pain
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%
Flu-like symptoms
4%
Memory impairment
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Edema trunk
4%
Sinus pain
4%
Vaginal dryness
4%
Head injury
4%
Watering eyes
4%
Dry eye
4%
Burn
4%
Back spasms
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%
Hypermagnesemia
2%
Photophobia
2%
Fungal toe infection
2%
Facial nerve disorder
2%
Diverticulitis
2%
Oral fissure
2%
Pharyngitis
2%
Paresthesia
2%
Vaginal discharge
2%
Vaginal itching
2%
Fever blister
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%
Agitation
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
Hemorrhoids
2%
Flank pain
2%
Wrist pain
2%
Sinus tachycardia
2%
Generalized weakness
2%
Intrascapular pain
2%
Paronychia
2%
Wrist fracture
2%
Cognitive disturbance
2%
Cold sweats
2%
Sepsis
2%
Bladder infection
2%
Eye lid pain
2%
Localized edema
2%
Respiratory syncytial virus (RSV)
2%
Leg pain
2%
Wound infection
2%
Rhinovirus
2%
Vaginal infection
2%
Radiation recall reaction (dermatologic)
2%
Urinary retention
2%
COPD
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bilateral nares sores
2%
Erythema multiforme
2%
Erythema right breast
2%
Nail loss
2%
Activated partial thromboplastin time prolonged
2%
Yeast infection
2%
Puncture wound
2%
Blood bilirubin increased
2%
Hyperuricemia
2%
Urine discoloration
2%
Sinus congestion
2%
Fracture
2%
Lung cancer
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
~3810

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,085 Previous Clinical Trials
341,560 Total Patients Enrolled
143 Trials studying Breast Cancer
22,692 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,550 Total Patients Enrolled
114 Trials studying Breast Cancer
36,195 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
~28 spots leftby Jul 2025
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