New drug cocktail shows promise in slowing HER2-Positive breast cancer

NCT ID NCT02947685

Disease control Sponsor: Alliance Foundation Trials, LLC. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding the drug palbociclib to standard anti-HER2 therapy and hormone therapy can help people with HR+/HER2+ metastatic breast cancer live longer without their cancer getting worse. About 518 participants who have already received initial treatment will be randomly assigned to either the triple-drug combo or standard therapy alone. The main goal is to see if the combo delays disease progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: palbociclib (Ibrance) combined with trastuzumab (Herceptin) and endocrine therapy
What this could lead to: If successful, this could offer a new treatment option that delays cancer progression for people with HR+/HER2+ metastatic breast cancer.
What could go wrong: This is an advanced trial, but adding palbociclib may increase side effects like low blood cell counts, and not all patients may benefit. The results may not apply to all breast cancer subtypes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

518 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Patients 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 recently biopsied metastatic disease if clinically feasible. This is recommended but optional tissue. 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 which is 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. Patients with a history or presence of asymptomatic 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 induction 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 below the upper limit of normal (ULN) of the institutional normal range 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

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer HER2 positive breast carcinoma triple-positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Estrogen-receptor-positive breast cancer HER 2 positive breast cancer

Contacts and locations

Locations

Agaplesion Markus Krankenhaus

Frankfurt, Germany
Auckland City Hospital Cancer and Blood Research

Auckland, New Zealand
Baycare Healthcare (Morton Plant Mease)

Clearwater, Florida, 33756, United States
Breast Cancer Research Centre-WA

Nedlands, Australia
CHU de Limoges

Limoges, France
Calvary Mater Newcastle Hospital

Waratah, Australia
Cancer Center of Kansas

Wichita, Kansas, 67214, United States
Centre Antoine Lacassagne

Nice, France
Centre Azureen de Cancerologie

Mougins, France
Centre CARIO-HPCA

Plérin, France
Centre Eugene Marquis

Rennes, France
Centre Francois Baclesse

Caen, France
Centre Georges François Leclerc

Dijon, France
Centre Henri Becquerel

Rouen, France
Centre Hospitalier Cholet

Cholet, France
Centre Jean Perrin

Clermont-Ferrand, France
Centre Léon Bérard

Lyon, France
Centre Oscar Lambret

Lille, France
Centre Paul Strauss

Strasbourg, France
Complejo Hospitalario Univ. De Santiago

Santiago, Spain
Complejo Hospitalario de Navarra

Navarro, Spain
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Diakovere Henriettenstift Frauenklinik

Hanover, Germany
Duke Cancer Institute

Durham, North Carolina, 27710, United States
Emory University

Atlanta, Georgia, 30322, United States
First Health of the Carolinas Cancer Center

Pinehurst, North Carolina, 28374, United States
Florida Hospital

Orlando, Florida, 32804, United States
Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States
Gustave Roussy

Villejuif, France
Hackensack Medical Center

Hackensack, New Jersey, 07601, United States
Hospital Beatriz Angelo

Loures, Portugal
Hospital Champalimaud

Lisbon, Portugal
Hospital Clínic de Barcelona

Barcelona, Spain
Hospital Clínico Universitario de Valencia

Valencia, Spain
Hospital Da Luz

Lisbon, Portugal
Hospital General de Catalunya

Barcelona, Spain
Hospital Quirón Sagrado Corazón

Seville, Spain
Hospital Regional Universitario de Málaga

Málaga, Spain
Hospital Sant Joan de Reus

Tarragona, Spain
Hospital Universitari Vall d'Hebron

Barcelona, Spain
Hospital Universitario 12 de Octubre

Madrid, Spain
Hospital Universitario Fundación Alcorcón

Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain
Hospital Universitario La Paz

Madrid, Spain
Hospital Universitario Virgen de la Arrixaca

Murcia, Spain
Hospital Universitario de Fuenlabrada

Madrid, Spain
Hospital Universitario de Salamanca

Salamanca, Spain
Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States
ICO L'Hospitalet

Barcelona, Spain
IPO Porto

Porto, Portugal
Icon Cancer Care

South Brisbane, Australia
Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States
Institut Bergonié

Bordeaux, France
Institut Curie Site Paris

Paris, France
Institut Curie Site Saint Cloud

Saint-Cloud, France
Institut Jean Godinot

Reims, France
Institut Paoli Calmettes

Marseille, France
Institut Sainte Catherine

Avignon, France
Institut de Cancerologie de Montpellier

Montpellier, France
Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France
Institut de Cancérologie de l'Ouest, site Paul Papin

Angers, France
Intitut Claudius Regaud

Toulouse, France
Istituto Europeo di Oncologia

Milan, Italy
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH

Essen, Germany
Legacy Good Samaritan Hospital

Portland, Oregon, 97210, United States
Leopoldina-Krankenhaus Schweinfurt

Schweinfurt, Germany
Lexington Medical Center

West Columbia, South Carolina, 29169, United States
Lowell General Hospital

Lowell, Massachusetts, 01854, United States
MD Anderson

Houston, Texas, 77030, United States
MD Anderson Cancer Center Spain

Madrid, Spain
Marienhospital Bottrop

Bottrop, Germany
Mater Cancer Care Centre

South Brisbane, Australia
Mayo Clinic, Rochester, MN

Rochester, Minnesota, 55905, United States
Memorial Healthcare System

Hollywood, Florida, 33021, United States
Metro-Minnesota NCI Community Oncology Research Program

Minneapolis, Minnesota, 55416, United States
Michigan Cancer Research Consortium (St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States
Monash Health

Clayton, Australia
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
New England Cancer Specialists

Scarborough, Maine, 04074, United States
New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87131, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Ohio State University

Columbus, Ohio, 43210, United States
Ospedale San Raffaele

Segrate, Italy
Ospedale Santa Maria della Misericordia

Udine, Italy
Peter MacCallum Cancer Centre, Royal Melbourne Hospital

Melbourne, Australia
Policlinico Sant'Orsola-Malpighi

Bologna, Italy
Praxis Prof. Nitz im Brustzentrum Niederrhein

Münster, Germany
St. Elisabeth Krankenhaus

Cologne, Germany
St. Vincent's Hospital, Sydney Kinghorn Cancer Centre

Darlinghurst, Australia
Tenon Oncologie Médicale - APHP

Paris, France
The Canberra Hospital

Garran, Australia
The Valley Hospital, Okonite Research Center

Paramus, New Jersey, 07652, United States
U.O. Oncologia AOU Arcispedale Sant'Anna

Cona, Italy
UCSF

San Francisco, California, 94115, United States
UKSH, Klinik für Gynäkologie und Geburtshilfe

Kiel, Germany
University of Illinois at Chicago

Chicago, Illinois, 60612, United States
University of Maryland - Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States
University of Miami

Miami, Florida, 33136, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States
Universitätsklinikum Münster

Münster, Germany
Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Michigan Cancer Center

Grand Rapids, Michigan, 49503, United States
Westmead Hospital

Westmead, Australia

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