Study on Palbociclib and Drug Combination for Patients with Hormone Receptor Positive, HER2-Positive Metastatic Breast Cancer

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What is this study about?

This clinical trial is focused on studying metastatic breast cancer, a type of breast cancer that has spread to other parts of the body. The study is investigating the effectiveness and safety of a treatment combination that includes palbociclib, an oral medication, along with anti-HER2 therapy and endocrine therapy. The goal is to see if this combination is better at delaying the progression of the disease compared to just using anti-HER2 therapy and endocrine therapy alone. Participants in the study will receive either the combination treatment or the standard treatment after an initial phase of treatment known as induction treatment.

The study will involve taking medications in the form of capsules or tablets, such as IBRANCE (which contains palbociclib) and other hormone therapies like exemestane, anastrozole, and letrozole. Some treatments, like fulvestrant, triptorelin, leuprorelin, and goserelin, will be given as injections. The study will also include anti-HER2 therapies like trastuzumab and pertuzumab, which are used to target specific proteins on cancer cells. The trial is designed to last for a period of time, during which participants will be monitored for any changes in their condition and any side effects they may experience.

The purpose of this study is to determine if the combination of palbociclib with anti-HER2 and endocrine therapies can provide better outcomes for patients with hormone receptor-positive, HER2-positive metastatic breast cancer. The study will assess how long patients live without their cancer getting worse, as well as overall survival rates and the response to treatment. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather important information about the effectiveness of the treatment.

1 joining the study

Upon joining the study, the patient will be required to sign a Main Informed Consent Form. This document confirms the patient’s understanding and agreement to participate in the trial.

A screening process will be conducted to ensure eligibility, which includes a review of medical history and current health status.

2 initial assessment

An initial assessment will be performed to establish baseline health metrics. This may include blood tests, imaging studies, and other necessary evaluations.

The patient must provide a tumor tissue sample, if feasible, for further analysis.

3 treatment phase

The treatment phase involves the administration of medications. The patient will receive a combination of palbociclib and anti-HER2 therapy along with endocrine therapy.

Palbociclib is available in capsule form and is taken orally. Dosages may vary, including 75 mg, 100 mg, or 125 mg, depending on the specific treatment plan.

Anti-HER2 therapies such as trastuzumab and pertuzumab are administered through injections or infusions.

Endocrine therapies may include medications like letrozole, exemestane, or anastrozole, which are taken orally.

4 monitoring and follow-up

Regular monitoring will be conducted to assess the patient’s response to treatment. This includes scheduled visits for physical examinations, laboratory tests, and imaging studies.

The patient’s health and any side effects experienced will be closely monitored to ensure safety and effectiveness of the treatment.

5 end of treatment

Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall response to the therapy.

The patient will be informed about the results and any further steps or follow-up care that may be necessary.

Who Can Join the Study?

  • You must sign a form called the Preliminary Screening Informed Consent Form before any study-related tests or procedures.
  • You should be able to swallow pills and not have any condition that affects how your body absorbs medication.
  • If you are a woman who can have children, you need a negative pregnancy test within 7 days before starting the study. If you are postmenopausal or have had certain surgeries like removal of ovaries or uterus, you may not need this test.
  • Both men and women in the study must use effective birth control during the study and for a period after the last treatment. This means using one highly effective method or two effective methods together.
  • Any side effects from previous cancer treatments should be resolved to a mild level, except for hair loss or other non-risky side effects. You can start the study 12 weeks after your last chemotherapy dose.
  • You must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures required by the study.
  • If you had previous treatments, you should have been free of cancer for at least 6 months after completing anti-HER2 therapy before being diagnosed with metastatic cancer.
  • You should have completed a specific type of chemotherapy with anti-HER2 therapy for metastatic breast cancer before joining the study. This includes a minimum of 4 cycles if you had significant side effects, but ideally 6 cycles. You can join the study immediately after finishing this treatment or within 12 weeks.
  • If you have cancer that has spread to the brain but have no symptoms, you can join if you meet certain conditions, like having no bleeding in the brain and not needing medication for seizures.
  • Your blood tests should show certain levels: white blood cells (neutrophils) at least 1,000/mm³, platelets at least 100,000/mm³, and hemoglobin at least 10g/dL.
  • You must be at least 18 years old.
  • Your liver and kidney function should be within certain limits, as shown by blood tests.
  • Your heart function should be at least 50% as measured by specific tests like ECHO or MUGA.
  • You must have confirmed invasive breast cancer that has spread or cannot be removed or treated with radiation to cure it.
  • Your cancer must be HER2 positive and hormone receptor positive, which means certain proteins are present in your cancer cells.
  • You must agree to provide a sample of your tumor tissue for testing, either from a previous surgery or a recent biopsy if possible.
  • You need to sign the Main Informed Consent Form before any study-related tests or procedures.
  • Your general health should be good, as measured by a scale called ECOG performance status, which should be 0 or 1.

Who Cannot Join the Study?

  • Patients who have already received treatment beyond the initial treatment for their metastatic breast cancer cannot participate. Metastatic breast cancer means the cancer has spread to other parts of the body.
  • Patients who are not diagnosed with hormone receptor-positive, HER2+ breast cancer are excluded. Hormone receptor-positive means the cancer cells grow in response to hormones. HER2+ means the cancer has a protein that promotes the growth of cancer cells.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
  • Both male and female patients can participate, but they must meet all other criteria.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Hospital Universitario De Navarra Pamplona Spain
Centre Jean Perrin Clermont Ferrand France
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Hopital Tenon Paris France
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH Schweinfurt Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Universitario 12 De Octubre Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Hospital Beatriz Angelo Loures Portugal
Hospital Quironsalud Sagrado Corazon Sevilla Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
MD Anderson Cancer Center Madrid Spain
Institut Godinot Reims France
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH Moenchengladbach Germany
Centre Henri Becquerel Rouen France
Centre Paul Strauss STRASBOURG, Alsace France
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Da Luz S.A. Lisbon Portugal
St. Elisabeth Krankenhaus GmbH Cologne Germany
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Salut Sant Joan De Reus Reus Spain
Centre Hospitalier De Cholet Cholet France
Hopital Prive Des Cotes D’armor Plerin France
Universita’ Degli Studi Di Ferrara Ferrara Italy
Institut Sainte Catherine Avignon France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Iwhilugo Rftivjlj Dj Cfdrhq Dm Mxukfenptxr Montpellier France
Dovulsnks Klyumreizga glyrz Hanover Germany
Cahads Lhab Bqofnb Lyon France
Ixpdlkrl Cvbpdk Dikdvvreamodcuyvu L'hospitalet De Llobregat Spain
Cjjlxk Atvttfw df Ckxshwggtrbr Mougins France
Cyvxqk Hrvojjqaayv Ee Uokuytanotudu Dq Llsubxu Limoges France
Utrqaucbrafpwbgdopdlf Mrxftfet Ajb Munster Germany
Kxgbtbls Bvlwxqvb Gclw Bayreuth Germany
Aehhwbj Ugkct Shdyoradu Lokczf Dx Bnfalvv Bologna Italy
Fmoenqsqo Pdis Lp Iauchqdeoekyi Bupuawsoi Dnk Hhrzwhpj Uefqpggnyidaa Lm Pbm Madrid Spain
Kpaejfdc Elaiggghekxkmvcbpubtbjpi Hgrpzbnbkvcfcazgl Essen Germany
Idyoxckv dz Cpclyfwjmels Hkdehzixnrk Ultgejvulyfkt dx Swizb Eotaolp (swjbimp Saint Priest En Jarez France
Hyjalzmj Vmvi daekgtwg Barcelona Spain
Igawucig Pboairpmroswsbp Cpvvis Cwvpxj Marseille France
Craswr Oaztp Lzqsbhn Lille France
Ieamokob Chcpd Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
21.06.2017
Germany Germany
Not recruiting
21.06.2017
Italy Italy
Not recruiting
21.06.2017
Portugal Portugal
Not recruiting
21.06.2017
Spain Spain
Not recruiting
21.06.2017

Trial locations

Palbociclib is a medication used in this trial to help treat metastatic breast cancer. It works by blocking certain proteins in cancer cells, which can slow down or stop the growth of the cancer. In this study, it is combined with other therapies to see if it can improve the treatment outcomes for patients with hormone receptor-positive, HER2-positive breast cancer.

Anti-HER2 Therapy refers to treatments that specifically target the HER2 protein, which can promote the growth of cancer cells. By blocking this protein, anti-HER2 therapies can help slow or stop the progression of the cancer. This therapy is used in combination with other treatments in the trial to evaluate its effectiveness in managing breast cancer.

Endocrine Therapy is a treatment that targets hormone receptor-positive breast cancer by interfering with the cancer’s ability to use hormones like estrogen or progesterone to grow. This therapy is often used to help slow down or stop the growth of hormone-sensitive tumors. In this trial, it is combined with other therapies to assess its role in treating metastatic breast cancer.

Investigated diseases:

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It often begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby tissues and lymph nodes. In some cases, it may metastasize to other parts of the body, such as bones, liver, or lungs. The progression can vary greatly among individuals, with some experiencing slow growth and others more rapid advancement. Hormone receptor-positive, HER2-positive breast cancer is a subtype that can influence the growth rate and spread of the disease.

Trial ID:
2024-513540-29-00
Protocol code:
AFT-38
Trial Phase:
Therapeutic confirmatory (Phase III)

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