Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/21/2018
Start Date:June 21, 2017
End Date:August 31, 2024
Contact:Jane S Lanzillotti, MS
Email:patina@alliancefoundationtrials.org

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A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

The primary objective of this study is to demonstrate that the combination of palbociclib
with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus
endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive,
HER2+ metastatic breast cancer.

Subjects will be randomized into one of two treatment arms following minimum of 4 and maximum
of 8 cycles of induction treatment with anti-HER2 therapy. Arm A subjects will receive the
experimental therapy, palbociclib, in addition to their current anti-HER2 therapy and
endocrine therapy. Arm B subjects will continue to receive the anti-HER2 therapy. It is
expected that the addition of palbociclib to the first-line treatment of HER2 disease will
delay the onset of therapeutic resistance and ultimately prolong the survival of patients
with metastatic breast cancer. The study is designed to treat the subset of patients with
HER2+ disease who are also hormone receptor positive (HR+). It is also expected that
palbociclib will modulate the endocrine resistance in HER2+/HR+ disease and potentiate the
benefits of anti-HER2 therapy. Lastly, the current study includes a comprehensive molecular
characterization of the disease at study entrance which will allow us to investigate the
benefits of palbociclib in subsets of HER2+/HR+ disease such as PIK3CA mutant.

Inclusion Criteria (Preliminary Screening)

1. Signed Preliminary Screening Informed Consent Form obtained prior to any study
specific assessments and procedures

2. Age ≥18 years (or per national guidelines)

3. Participants must have histologically confirmed invasive breast cancer that is
metastatic or not amenable for resection or radiation therapy with curative intent.
Histological documentation of metastatic/recurrent breast cancer is not required if
there is unequivocal evidence for recurrence of the breast cancer.

4. Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+
and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be
performed according to institutional guidelines, in a CLIA-approved setting in the US
or certified laboratories for Non-US regions. 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.

5. Patients must agree to provide a representative formalin-fixed paraffin-embedded
(FFPE) tumor tissue block (preferred) from primary breast or metastatic site
(archival) OR at least 15 freshly cut unstained slides from such a block, along with a
pathology report documenting HER2 positivity and hormone receptor positivity.

6. Patients should be willing to provide a representative tumor specimen obtained from
metastatic disease if clinically feasible. This is a recommended but optional research
biopsy.

Inclusion Criteria (Randomization Screening)

7. Signed Main Informed Consent Form obtained prior to any study specific assessments and
procedures

8. Age ≥ 18 years (or per national guidelines)

9. ECOG performance status 0-1

10. Patients must be able and willing to swallow and retain oral medication without a
condition that would interfere with enteric absorption.

11. Serum or urine pregnancy test must be negative within 7 days of randomization in women
of childbearing potential. Pregnancy testing does not need to be pursued in patients
who are judged as postmenopausal before randomization, as determined by local
practice, or who have undergone bilateral oophorectomy, total hysterectomy, or
bilateral tubal ligation. Women of childbearing potential and male patients randomized
into the study must use adequate contraception for the duration of protocol treatment
and for 6 months after the last treatment with palbociclib if they are in Arm A and
for 7 months after last treatment with trastuzumab if in either Arm A or Arm B
Adequate contraception is defined as one highly effective form (i.e. abstinence,
(fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom /
occlusive cap with spermicidal foam / gel / film / cream / suppository).

12. Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy
regimen to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not
considered a safety risk for the patient at investigator's discretion) 12 weeks
between last dose of chemotherapy-anti-HER2therapy and randomization are allowed.
Endocrine therapy could start before study randomization.

13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures

Prior Treatment Specifics

14. Patients may or may not have received neo/adjuvant therapy, but must have a
disease-free interval from completion of anti-HER2 therapy to metastatic diagnosis ≥6
months.

15. Patients must have received an acceptable, standard, chemotherapy containing anti-HER2
based induction therapy for the treatment of metastatic breast cancer prior to study
enrollment. For this study, chemotherapy is limited to a taxane or vinorelbine (only
for trastuzumab-based regimen). Eligible patients are expected to have completed 6
cycles of chemotherapy containing anti-HER2-therapy treatment. A minimum of 4 cycles
of treatment is acceptable for patients experiencing significant toxicity associated
with treatment as long as they are without evidence of disease progression (i.e. CR,
PR or SD). The maximum number of cycles is 8. Patients can randomize immediately
following completion of their induction therapy, or for those who have already
completed induction, a gap of 12 weeks between their last infusion/dose of induction
therapy and the C1D1 visit is permitted. Patients are eligible provided they are
without evidence of disease progression by local assessment (i.e. CR, PR or SD).

16. Participants with a history of treated CNS metastases are eligible, provided they meet
all of the following criteria:

- Disease outside the CNS is present.

- No evidence of interim progression between the completion of CNS-directed therapy
and the screening radiographic study

- No history of intracranial hemorrhage or spinal cord hemorrhage

- Not requiring anti-convulsants for symptomatic control

- Minimum of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and
recovery from significant (Grade ≥ 3) acute toxicity with no ongoing requirement
for corticosteroid

Baseline Body Function Specifics

17. Absolute neutrophil count ≥ 1,000/mm3

18. Platelets ≥ 100,000/mm3

19. Hemoglobin ≥ 10g/dL

20. Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin
within normal range in patients with documented Gilbert's Syndrome.

21. Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤
3 × institutional ULN (≤5 x ULN if liver metastases are present).

22. Serum creatinine within normal institutional limits or creatinine clearance ≥ 60
mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

23. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either
ECHO or MUGA

Exclusion Criteria (Randomization)

1. Concurrent therapy with other Investigational Products.

2. Prior therapy with any CDK 4/6 inhibitor.

3. History of allergic reactions attributed to compounds of chemical or biologic
composition similar to palbociclib.

4. Patients receiving any medications or substances that are strong inhibitors or
inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for
list of strong inhibitors or inducers of CYP3A isoenzymes).

5. Uncontrolled current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, diabetes, or psychiatric illness/social situations that would limit
compliance with study requirements. Ability to comply with study requirements is to be
assessed by each investigator at the time of screening for study participation.

6. Pregnant women, or women of childbearing potential without a negative pregnancy test
(serum or urine) within 7 days prior to randomization, irrespective of the method of
contraception used, are excluded from this study because the effect of palbociclib on
a developing fetus is unknown. Breastfeeding must be discontinued prior to study
entry.

7. Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are
ineligible because of the potential for pharmacokinetic interactions or increased
immunosuppression with palbociclib.

8. QTc interval >480 msec, Brugada syndrome or known history of QTc prolongation or
Torsade de Pointes.

9. Patients with clinically significant history of liver disease, including viral or
other known hepatitis, current alcohol abuse, or cirrhosis
We found this trial at
52
sites
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Kent Hoskins, MD
University of Illinois at Chicago A major research university in the heart of one of...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Jane Meisel, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Kathleen Harnden, MD
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Carmen Calfa, MD
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Ingrid Mayer, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Ali Conlin, MD
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Albuquerque, New Mexico 87109
Principal Investigator: Ursa Brown-Glaberman, MD
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Ann Arbor, Michigan 48106
Principal Investigator: Elie Dib, MD
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Annapolis, Maryland 21401
Principal Investigator: Carol Tweed, MD
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Katherine Tkaczuk, MD
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Vered Stearns, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Otto Metzger, MD
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33 Whiting Hill Road
Brewer, Maine 04412
Principal Investigator: Sarah Sinclair, MD
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Charlotte, North Carolina 28204
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1200 West Loyola Avenue
Chicago, Illinois 60626
Principal Investigator: Kathy Albain, MD
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Olwen Hahn, MD
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Clearwater, Florida 33756
Principal Investigator: Ben Yan, MD
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Sagar Sardesai, MD
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Principal Investigator: Kelly Westbrook, MD
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Edgewood, Kentucky 41017
Principal Investigator: Daniel Flora, MD
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555 East Cheves Street
Florence, South Carolina 29506
843-777-2000
Principal Investigator: Rajesh Bajaj, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Kathleen Yost, MD
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Hackensack, New Jersey 07601
Principal Investigator: Deena Graham, MD
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Principal Investigator: Kimberly Kruczek, MD
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Hollywood, Florida
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Houston, Texas 77030
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Peter Kaufman, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
Principal Investigator: Richard Zuniga, MD
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Miami Beach, Florida 33140
Principal Investigator: Michael Schwartz, MD
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Minneapolis, Minnesota 55416
Principal Investigator: Rachel Lerner, MD
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New Orleans, Louisiana 70121
Principal Investigator: John Cole, MD
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8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Principal Investigator: Kirsten Leu, MD
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Pavankumar Tandra, MD
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Carlos Alemany, MD
Florida Hospital Florida Hospital is one of the country
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Paramus, New Jersey 07652
Principal Investigator: Eleonora Teplinsky, MD
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Paterson, New Jersey 07503
Principal Investigator: Michael Maroules, MD
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Peoria, Illinois 61615
Principal Investigator: Nguyet Le-Lindqwister, MD
Phone: 309-243-3000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Angela DeMichele, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85054
Principal Investigator: Donald Northfelt, MD
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Pinehurst, North Carolina 28374
Principal Investigator: Charles Kuzma, MD
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3459 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Adam Brufsky, MD
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Portland, Oregon 97210
Principal Investigator: Regan Look, MD
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Puyallup, Washington 98372
Principal Investigator: Lavanya Sundararajan, MD
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Rochester, Minnesota 55905
Principal Investigator: Matthew Goetz, MD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Haeseong Park, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Norah Lynn Henry, MD
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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1635 Divisadero Street
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Principal Investigator: Amy Jo Chien, MD
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Scarborough, Maine 04074
Principal Investigator: Chiara Battelli, MD
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Towson, Maryland 21204
Principal Investigator: Rima Couzi, MD
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Paula Pohlmann, MD
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West Columbia, South Carolina 29169
Principal Investigator: Steven Madden, MD
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
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