← Back to Search
Hormone Therapy
Combination Therapy for Breast Cancer
Indianapolis, IN
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
No Placebo-Only Group
Summary
This trial is testing if any of these combinations can help treat breast cancer.
See full description
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.
show original
Select...
My breast cancer is hormone receptor positive and HER2 negative, and cannot be surgically removed.
show original
Select...
I have been on hormone and CDK4/6 therapy for my cancer for at least 6 months without it getting worse.
show original
Select...
I am 18 years old or older.
show original
Select...
I can swallow and keep down pills.
show original
Select...
My cancer progressed after treatment with endocrine therapy and CDK 4/6 inhibitors.
show original
Select...
I can carry out all my usual activities without help.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any medications that affect my heart's rhythm.
show original
Select...
I am not pregnant and will not breastfeed if I join the study.
show original
Select...
I am HIV positive or have AIDS and may need antiretroviral therapy.
show original
Select...
I have a history of immune conditions like colitis or lung issues needing steroids.
show original
Select...
I am allergic to palbociclib or similar medications.
show original
Select...
My cancer is spreading quickly and could soon lead to life-threatening issues.
show original
Select...
I have had an organ or stem-cell transplant.
show original
Select...
I am not taking any strong medication that affects liver enzymes.
show original
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability)
Overall Response Rate, According to RECIST v1.1 Criteria (Investigator Assessment)
Side effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850763%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Mucositis
17%
Headache
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Arthralgia
13%
Hypothermia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Upper respiratory infection
11%
Cough
10%
Flu like symptoms
10%
Obesity
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dyspepsia
7%
Dizziness
7%
Hot flashes
7%
Bone pain
7%
Pruritus
5%
Dysgeusia
5%
Pain
3%
Nail disorder
3%
Abdominal pain
3%
Respiratory infection
1%
Dyspnea
1%
Renal failure
1%
Bronchial infection
1%
Heart failure
1%
Breast infection
1%
Pleural effusion
1%
Dislocation of hip
1%
Osteonecrosis of jaw
1%
Spinal cord compression
1%
Gallbladder infection
1%
Ascites
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Cholecystitis acute
1%
Urinary tract infection
1%
Thromboembolic event
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
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
~3910
Avelumab
2017
Completed Phase 2
~2450
Fulvestrant
2011
Completed Phase 3
~4160
Find a Location
Closest Location:Indiana University· Indianapolis, IN· 168 miles
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,126 Previous Clinical Trials
361,042 Total Patients Enrolled
146 Trials studying Breast Cancer
20,288 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,704 Previous Clinical Trials
50,981,312 Total Patients Enrolled
118 Trials studying Breast Cancer
42,503 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.