Study Comparing Two Treatment Sequences of CDK4/6 Inhibitors (Abemaciclib, Palbociclib, or Ribociclib) in Hormone Receptor Positive Advanced Breast Cancer

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What is this study about?

This clinical trial studies treatments for hormone receptor-positive breast cancer that has spread to other parts of the body (advanced or metastatic). The study compares two different treatment strategies using medications called CDK4/6 inhibitors (including abemaciclib, palbociclib, and ribociclib) combined with hormone therapy. These medications work by blocking proteins that help cancer cells grow.

The main purpose is to determine which treatment sequence works better: using a CDK4/6 inhibitor with hormone therapy first, followed by fulvestrant alone when the disease progresses; or starting with hormone therapy alone, followed by fulvestrant combined with a CDK4/6 inhibitor when the disease progresses. Additional hormone therapies that may be used include anastrozole, letrozole, goserelin, and leuprorelin.

During the study, patients will receive treatment until their disease progresses or they cannot tolerate the medication. The researchers will monitor how long it takes for the cancer to progress after both first and second treatments, overall survival, quality of life, and side effects. They will also collect tumor samples and blood tests to study markers that might help predict which patients respond best to treatment.

1 Initial treatment phase – Strategy A or B

You will be assigned to one of two treatment strategies:

Strategy A: You will receive a non-steroidal aromatase inhibitor combined with CDK4/6 inhibitor tablets as first treatment

Strategy B: You will receive only a non-steroidal aromatase inhibitor tablets as first treatment

If you are not in post-menopause, you will also receive hormone therapy to suppress ovarian function

2 Regular medical evaluations

Your health status will be regularly monitored through blood tests and imaging

Your doctor will assess how well the treatment is working

Side effects will be monitored and recorded

Quality of life assessments will be conducted

3 Second treatment phase

If the disease progresses during the first treatment:

Strategy A: You will receive fulvestrant alone

Strategy B: You will receive fulvestrant combined with CDK4/6 inhibitor tablets

Regular monitoring will continue as in the previous phase

4 Additional assessments

Blood samples will be collected to analyze tumor DNA

Imaging scans will be performed to evaluate treatment response

Cognitive function will be assessed through online tests

The study will continue until December 2028

Who Can Join the Study?

  • Must be a female adult aged 18 or older
  • Must have breast cancer that has spread locally or to other parts of the body (metastatic) that cannot be treated with surgery or radiation therapy with the aim of cure
  • Must have breast cancer that tests positive for certain hormones (estrogen receptor >10% and/or progesterone receptor >10%) and negative for HER2 protein
  • Must not have received any previous systemic treatment for metastatic breast cancer, except for hormone therapy started within the last 28 days
  • If not post-menopausal, must be willing to receive treatment to stop ovarian function
  • Must have cancer that can be measured using standard imaging techniques
  • Must have a good general health status (ECOG performance status of 0-2, meaning able to perform most daily activities)
  • Must have adequate organ function, including:
    • Sufficient white blood cell counts
    • Sufficient platelet counts
    • Adequate kidney function
    • Acceptable liver function
  • Must have recovered from side effects of any previous cancer treatments, with most side effects resolved or mild (except for hair loss)

Who Cannot Join the Study?

  • Previous systemic treatment for metastatic breast cancer
  • Male patients (study is for females only)
  • Age below 18 years
  • Known HER2-positive breast cancer (where cancer cells have too much of a protein called HER2 on their surface)
  • Known hormone receptor-negative breast cancer (cancer cells that do not have receptors for estrogen or progesterone)
  • Prior treatment with CDK4/6 inhibitors (medications that block specific proteins involved in cell growth)
  • Prior treatment with aromatase inhibitors (medications that lower estrogen levels) for metastatic disease
  • Prior treatment with fulvestrant (a hormone therapy that blocks estrogen receptors)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Pregnancy or breastfeeding
  • Serious heart conditions or uncontrolled high blood pressure
  • Severe liver or kidney problems
  • Active serious infections
  • Other active cancers requiring treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Frisius Heerenveen The Netherlands

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Groene Hart Ziekenhuis Gouda The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Ziekenhuis Rivierenland Tiel The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Diakonessenhuis Stichting Utrecht The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Elkerliek Ziekenhuis Helmond The Netherlands
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Ziekenhuis St Jansdal Harderwijk The Netherlands
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
Het Van Weel-Bethesda Ziekenhuis Dirksland The Netherlands
Rode Kruis Ziekenhuis B.V. Beverwijk The Netherlands
Ziekenhuis Nij Smellinghe Drachten The Netherlands
Saxenburgh Medisch Centrum Hardenberg The Netherlands
Bernhoven B.V. Uden The Netherlands
Ziekenhuis Amstelland Amstelveen The Netherlands
Flevoziekenhuis Stichting Almere The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Stichting Treant Ziekenhuiszorg Emmen The Netherlands
Zaans Medisch Centrum Stichting Zaandam The Netherlands
Bravis Ziekenhuis Roosendaal The Netherlands
Slingeland Ziekenhuis Doetinchem The Netherlands
Wilhelmina Ziekenhuis Assen Assen The Netherlands
Gelre Hospitals Zutphen The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Dijklander Ziekenhuis Hoorn The Netherlands
Ltmmn Uewaebhkquzk Mjeaxxa Cvnaxhd (remyr Leiden The Netherlands
Rrwgaazzr Zyagjfgqsc Sihkislzu Arnhem The Netherlands
Ubvxbveqrbte Mdevyoc Cxbyxhx Gbklylyyn Groningen The Netherlands
Sqxxjpcym Mmnolnr Zkmiarispp Groningen The Netherlands
Mvlakewhsizvpt Pzwzbyo Bxvo Beugen The Netherlands
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Akhcxhtbt Mfptt Zjezoipcgb Slymwmurl Bilthoven The Netherlands
Lnvjrybtai Zaeeybcygh Rojofjwo Roermond The Netherlands
Brgryal Zznnoancpr Gorinchem The Netherlands
Slqdwbcsxfirfops Kmvixlqk Btrbmqd Winterswijk The Netherlands
Iqdgbuavvh Zgydzncgsq Capelle Aan Den Ijssel The Netherlands
Svzfdbj Geldrop The Netherlands
Ajvfnwww zkvhenbrfs Skkip Sneek The Netherlands
Ajaffkrxr Unu Amsterdam The Netherlands
Excveqm Uuwcpdwgykqg Mtbamdw Crqpgwq Rnvdplfce (ojkpdbi Mix Rotterdam The Netherlands
Soz Epkcgoggz Hbqalrnw Tfvltkg Tilburg The Netherlands
Sjekvptcs Bxpimtk Amsterdam The Netherlands
Sik Jyal Gdgwmtge Wofjq Weert The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.10.2017

Trial locations

Non-steroidal aromatase inhibitors are medications that lower estrogen levels in the body. They work by blocking an enzyme called aromatase, which helps produce estrogen. These medications are commonly used to treat hormone receptor-positive breast cancer.

CDK4/6 inhibitors are targeted therapy medications that work by blocking specific proteins called CDK4 and CDK6, which help cancer cells grow and divide. These medications are used in combination with hormone therapy to treat hormone receptor-positive breast cancer.

Fulvestrant is a hormone therapy medication that blocks and degrades estrogen receptors in cancer cells. It works differently from aromatase inhibitors and is often used when breast cancer has progressed after other hormone treatments. It’s given as an injection and helps slow down or stop the growth of hormone receptor-positive breast cancer.

Breast Cancer – A disease that begins when cells in the breast tissue start to grow out of control. It typically starts in either the ducts that carry milk to the nipple or the glands that make breast milk. As the cancer cells multiply, they can form a tumor that can often be felt as a lump or seen on an x-ray. The cancer cells can spread into surrounding breast tissue and potentially to other parts of the body. This disease can occur in both women and men, though it’s much more common in women. Breast cancer may be influenced by various factors including genetic, hormonal, and environmental components.

Trial ID:
2024-516204-42-00
Protocol code:
BOOG 2017-03
NCT ID:
NCT03425838
Trial Phase:
Therapeutic confirmatory (Phase III)

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