← Back to Search

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

No Placebo-Only Group

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.

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.

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

Select...

My kidney function, measured by creatinine levels, is normal or nearly normal.

Select...

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.

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.

Select...

I am not pregnant and will not breastfeed if I join the study.

Select...

I am HIV positive or have AIDS and may need antiretroviral therapy.

Select...

I have a history of immune conditions like colitis or lung issues needing steroids.

Select...

I am allergic to palbociclib or similar medications.

Select...

My cancer is spreading quickly and could soon lead to life-threatening issues.

Select...

I have had an organ or stem-cell transplant.

Select...

I am not taking any strong medication that affects liver enzymes.

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).

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

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 • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Flu like symptoms

10%

Obesity

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Dysgeusia

Pain

Nail disorder

Respiratory infection

Abdominal pain

Spinal cord compression

Heart failure

Bronchial infection

Pleural effusion

Ascites

Urinary tract infection

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Dislocation of hip

Palmar-plantar erythrodysesthesia syndrome

Osteonecrosis of jaw

Thromboembolic event

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

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

~3790

Avelumab

2017