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Timing is everything: new study seeks best sequence for breast cancer combo therapy

NCT ID NCT03425838

Disease control Sponsor: Borstkanker Onderzoek Groep Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding a CDK4/6 inhibitor (a targeted drug) to hormone therapy earlier or later works better for women with advanced hormone-receptor-positive breast cancer. About 1,050 women will receive either the drug combo first followed by another hormone therapy, or hormone therapy first followed by the combo. The goal is to see which sequence helps control the cancer longer without worsening quality of life.

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

1,050 people

The number who actually took part.

Started

Nov 2017

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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

Female participants only

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: 1. Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated. 2. Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor (ER) expression \>10% and/or progesterone receptor (PR) expression \>10% breast cancer based on local laboratory results. 3. Previously untreated with any systemic anti-cancer therapy for loco-regional recurrent or metastatic HR+ disease, with the exception of recently started (within 28 days of randomization) endocrine therapy. 4. Women who are not post-menopausal must use LHRH agonist. Postmenopausal status is defined as: 1. prior bilateral surgical oophorectomy, or 2. spontaneous cessation of regular menses for at least 12 consecutive months without OAC 3. in case of doubt serum estradiol \<20 umol/l and follicle stimulating hormone (FSH) levels \>15 IU/L at screening 5. Measurable or evaluable disease as defined per RECIST v.1.1 (see Appendix 3) or bone-only disease. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 7. Adequate organ and marrow function defined as follows: 1. ANC ≥1,000/mm3 (1.0 x 10e9 /L); 2. Platelets ≥50,000/mm3 (50 x 10e9 /L); 3. Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution; 4. Total serum bilirubin ≤1.5 x ULN (≤3.0 x ULN if Gilbert's disease); 5. AST and ALT ≤3 x ULN (≤5.0 x ULN if liver metastases present); 8. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures 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. 9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 10. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study before any study-specific activity is performed. Exclusion Criteria: 1. Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement). 2. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable without the use of steroids for at least 4 weeks before randomization 3. Prior neoadjuvant or adjuvant treatment with an aromatase inhibitor (i.e., anastrozole, letrozole or exemestane) with disease recurrence while on or within 12 months of treatment. 4. Prior treatment with any CDK4/6 inhibitor. 5. Patients treated within the last 7 days prior to randomization with: 1. Food or drugs that are known to be CYP3A4 inhibitors (ie, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit or grapefruit juice); 2. Drugs that are known to be CYP3A4 inducers (ie, carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentin, and St. John's wort). 6. Major surgery, chemotherapy, radiotherapy, any investigational agents, or other anti-cancer therapy within 2 weeks before randomization. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received. 7. Diagnosis of any other malignancy prior to randomization, except those that are not believed to influence the patient's prognosis and do not require any further treatment. This includes, but is not limited to adequately treated basal cell or squamous cell skin cancer and carcinoma in situ of the cervix. 8. QTc \>480 msec at baseline 9. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection. 10. Known hypersensitivity to letrozole or anastrozole, or any of its excipients, or to any palbociclib excipients. 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 12. Recent or active suicidal ideation or behavior.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast neoplasm female

Contacts and locations

Locations

  • AMC

    Amsterdam, Netherlands

  • Admiraal de Ruyter

    Goes, Netherlands

  • Albert Schweitzer ziekenhuis

    Dordrecht, Netherlands

  • Alexander Monro Ziekenhuis

    Bilthoven, Netherlands

  • Alrijne Ziekenhuis

    Leiden, Netherlands

  • Amphia

    Breda, Netherlands

  • Antonius Ziekenhuis

    Sneek, Netherlands

  • Bernhoven

    Uden, Netherlands

  • BovenIJ Ziekenhuis

    Amsterdam, Netherlands

  • Bravis ziekenhuis

    Roosendaal, Netherlands

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • Deventer Ziekenhuis

    Deventer, Netherlands

  • Diakonessenhuis

    Utrecht, Netherlands

  • Dijklander Ziekenhuis

    Hoorn, Netherlands

  • Elisabeth Tweesteden

    Tilburg, Netherlands

  • Elkerliek ziekenhuis

    Helmond, Netherlands

  • Erasmus MC

    Rotterdam, 3015 CE, Netherlands

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Franciscus Gasthuis & Vlietland

    Rotterdam, Netherlands

  • Gelderse Vallei

    Ede, Netherlands

  • Gelre ziekenhuizen

    Apeldoorn, Netherlands

  • Groene Hart Ziekenhuis

    Gouda, Netherlands

  • HaGaziekenhuis

    The Hague, Netherlands

  • Haaglanden Medisch Centrum

    The Hague, Netherlands

  • IJsselland

    Capelle aan den IJssel, Netherlands

  • Ikazia

    Rotterdam, Netherlands

  • Isala

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • LUMC

    Leiden, Netherlands

  • Langeland

    Zoetermeer, Netherlands

  • Laurentius

    Roermond, Netherlands

  • MC Leeuwarden

    Leeuwarden, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • Maasziekenhuis Pantein

    Boxmeer, Netherlands

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, Netherlands

  • Meander Medisch Centrum

    Amersfoort, Netherlands

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Nij Smellinghe

    Drachten, Netherlands

  • Nki - Avl

    Amsterdam, 1066 CX, Netherlands

  • Noordwestziekenhuisgroep

    Alkmaar, Netherlands

  • OLVG

    Amsterdam, Netherlands

  • Radboudumc

    Nijmegen, Netherlands

  • Reinier de Graaf

    Delft, Netherlands

  • Rijnstate

    Arnhem, Netherlands

  • Rivas Beatrixziekenhuis

    Gorinchem, Netherlands

  • Rode Kruis Ziekenhuis

    Beverwijk, Netherlands

  • Ropcke Zweers

    Hardenberg, Netherlands

  • Sint Jansdal

    Harderwijk, Netherlands

  • Slingeland Ziekenhuis

    Doetinchem, Netherlands

  • Spaarne Gasthuis

    Hoofddorp, Netherlands

  • Spijkenisse Medisch Centrum

    Spijkenisse, Netherlands

  • St. Anna Ziekenhuis

    Geldrop, Netherlands

  • St. Antonius

    Nieuwegein, Netherlands

  • St. Jans Gasthuis

    Weert, Netherlands

  • Streekziekenhuis Koningin Beatrix

    Winterswijk, Netherlands

  • Tergooi

    Hilversum, Netherlands

  • Tjongerschans

    Heerenveen, Netherlands

  • Treant Zorggroep

    Emmen, Netherlands

  • UMC Groningen

    Groningen, Netherlands

  • UMC Utrecht

    Utrecht, Netherlands

  • VUmc

    Amsterdam, 1081 HV, Netherlands

  • Van Weel-Bethesda Ziekenhuis

    Dirksland, Netherlands

  • VieCuri

    Venlo, Netherlands

  • Wilhelmina ziekenhuis

    Assen, Netherlands

  • ZGT

    Almelo, Netherlands

  • Zaans Medisch Centrum

    Zaandam, Netherlands

  • Ziekenhuis Amstelland

    Amstelveen, Netherlands

  • Ziekenhuis Rivierenland

    Tiel, Netherlands

  • ZorgSaam

    Terneuzen, Netherlands

  • Zuyderland

    Sittard, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.