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Breast CancerPhase 2INGE-BNCT02894398

Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

A Phase 2 study testing Palbociclib, Letrozole and Anastrozole in people with Breast Cancer and Hormone Receptor Positive Tumor, run by iOMEDICO AG at 70 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline therapy in combination with palbociclib (Ibrance) Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Palbociclib, Letrozole and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
70 sitesGermany
Study dates
6 Sep 2016to 15 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Personally signed written informed consent prior to beginning protocol specific procedures, including expected cooperation of the patient for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
  • Women with proven diagnosis of advanced, defined as locally advanced inoperable or metastatic, adenocarcinoma of the breast
  • Hormone-receptor-positive (HR+) disease, defined as estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+)
  • Human epidermal growth factor receptor 2-negative (HER2-) disease (HER2 neg/+ or HER2++ with CISH/FISH neg.)
  • Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist / ovarian ablation or postmenopausal status
  • Age ≥18 years
Show all 12Show fewer
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors [RECIST] or bone-only disease
  • Patients scheduled for palliative treatment with an combination partner for first- or later-line
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate organ and marrow function
  • Resolution of all acute toxic effects of prior therapy, including radiotherapy Grade <1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures
  • Fluent in spoken and written German

Who cannot join

  • Prior treatment with any CDK4/6 inhibitor
  • Prior adjuvant therapy with the respective endocrine combination partner if last intake <12 months prior to entering the study
  • Prior palliative therapy with the respective endocrine combination partner
  • More than one prior palliative chemotherapy
  • 5. Known hypersensitivity to letrozole, anastrozole, exemestane, fulvestrant or any of their excipients
  • Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 (refer to Appendix 15.4)
Show all 13Show fewer
  • Current use of preparations containing St. John's Wort
  • Participation in other studies involving investigational drug(s) (Phases I-IV) within 2 weeks before the current study treatment begins
  • QTc > 480 msec on the screening ECG (using the QTcF formula and/or the QTcB (Bazett) formula); history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
  • High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment
  • Patients with advanced symptomatic, visceral spread, that were 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)
  • Diagnosis of any second malignancy within the last 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • Known, not-irradiated CNS metastases

Trial locations and contacts

70 sites in 1 country.

70 sites in 1 country

Germany70 sites

  • Research Site

    Aachen

  • Research Site

    Aschaffenburg

  • Study site

    Augsburg

  • Research Site

    Baden-Baden

  • Research Site

    Berlin

  • Study site

    Bochum

  • Study site

    Bonn

  • Research Site

    Bottrop

  • Study site

    Bremerhaven

  • Research Site

    Celle

  • Study site

    Dessau

  • Research Site

    Donauwörth

  • Research Site

    Dortmund

  • Research Site

    Dresden

  • Research Site

    Essen

  • Research Site

    Esslingen am Neckar

  • Research Site

    Frankfurt

  • Research Site

    Freiburg im Breisgau

  • Research Site

    Gerlingen

  • Study site

    Goslar

  • Research Site

    Göttingen

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Güstrow

  • Research Site

    Gütersloh

  • Research Site

    Halle

  • Research Site

    Hamburg

  • Study site

    Homburg

  • Study site

    Ilsede

  • Study site

    Kaiserslautern

  • Research Site

    Karlsruhe

  • Research Site

    Kassel

  • Research Site

    Krefeld

  • Research Site

    Langen

  • Research Site

    Leer

  • Study site

    Loerrach

  • Study site

    Lübeck

  • Study site

    Lüneburg

  • Study site

    Mannheim

  • Study site

    Minden

  • Research Site

    Mönchengladbach

  • Research Site

    Mühlhausen

  • Study site

    Mülheim

  • Research Site

    München

  • Study site

    München

  • Research Site

    Münster

  • Study site

    Neumünster

  • Study site

    Neuruppin

  • Study site

    Offenburg

  • Study site

    Oldenburg

  • Study site

    Passau

  • Study site

    Potsdam

  • Research Site

    Recklinghausen

  • Research Site

    Regensburg

  • Study site

    Rostock

  • Study site

    Saarbrücken

  • Study site

    Schorndorf

  • Research Site

    Singen

  • Study site

    Speyer

  • Study site

    Stade

  • Study site

    Stolberg

  • Study site

    Stuttgart

  • Study site

    Traunstein

  • Research Site

    Ulm

  • Study site

    Villingen-Schwenningen

  • Study site

    Westerstede

  • Research Site

    Wilhelmshaven

  • Study site

    Witten

  • Study site

    Würselen

  • Study site

    Würzburg

Other trials in Germany

About this study

Official title: Open-label, Multi-center, sINGlE Arm Clinical Study to Evaluate Efficacy/QoL in Women With HR+, HER2-, Regionally Recurrent or Metastatic Breast Cancer Receiving Palbociclib With an AI or Fulvestrant After Prior Endocrine Therapy

The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline therapy in combination with palbociclib (Ibrance)

Read the detailed description

This is a prospective, open-label, multi-center, single arm, non-comparative phase II study in women with HR+/HER2- advanced breast cancer receiving palbociclib in addition to an aromatase inhibitor or fulvestrant. The study will take place in Germany (85 study centers).

In total, 360 patients will be enrolled in this study. 6 treatment groups are planned. The study seeks to recruit 60 (58-62) patients per recruitment group. For first-line treatment with palbociclib - and letrozole (Enrollment Group 1), anastrozole (Enrollment Group 2), exemestane (Enrollment Group 3) or fulvestrant (Enrollment Group 4) and 60 (58-62) patients for second- or later-line treatment with palbociclib -and letrozole (Enrollment Group 5) or fulvestrant (Enrollment Group 6). Recruitment will be centrally monitored to allow closure of a respective group as soon as 60 (58-62) patients have been enrolled.

Treatment will be continued until disease progression, intolerable toxicity, death or any other reason. In case a combination partner is discontinued, palbociclib has to be discontinued. In case treatment with palbociclib is stopped, combination partner can be continued according to investigator's discretion. Irrespectively of the combination partner, the discontinuation of palbociclib is defined as end of treatment (EOT) in this study. After EOT the patient enters the follow-up period.

Primary end point is clinical benefit rate 24 weeks after the first study treatment of the patient.

A study independent, decentral, "virtual" biobank will be established. All patients will be asked to give consent for their tumor samples to be used for future investigational research. Study sites will inform the local pathologists about the patient's consent and ask for the tissue sample to be reserved for future analyses. The site is requested to collect contact details of the pathologist storing the tumor sample, the sample's identification number(s), and to document these in the eCRF.

The decision to perform subsequent investigational research studies on collected samples will be based on outcome data from this study or from new scientific findings related to the drug class or disease, as well as reagent and assay availability.

Being tested
Palbociclib, Letrozole, Anastrozole, Exemestane, Fulvestrant
Keywords
HR+, HER2-, Locally advanced (inoperable or metastatic) Breast Cancer, Palbociclib, Aromatase inhibitor or fulvestrant, Pre-/perimenopausal receiving LHRH agonist / ovarian ablation, Postmenopausal
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    Also called Ibrance

    Capsules (commercially available, obtained from local pharmacies), 125mg daily, 21 days, 7 days off, cycles of 28 days.

    Dose reductions: 100mg, 75mg (no change in administration schedule) Number of cycles: until disease progression, intolerable toxicity, death or any other reasons

  • LetrozoleDrug

    Also called Femara

    Letrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 2.5mg/daily, oral intake

  • AnastrozoleDrug

    Also called Arimidex

    Anastrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 1mg/daily, oral intake

  • ExemestaneDrug

    Also called Aromasin

    Exemestane will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 25mg/daily, oral intake

  • FulvestrantDrug

    Also called Faslodex

    Fulvestrant will be administered as basic therapy (commercially available injection, obtained from local pharmacies) as followed: 500mg/once monthly, intramuscular injection

Study groups in NCT02894398
Study groupRoleWhat they receive
Palbociclib+AI or FulvestrantExperimentalLetrozole as first-line or later line, Anastrozole as first-line, Exemestane as first-line, Fulvestrant as first-line or later line after prior endocrine therapy.
Receives: Drug: Palbociclib; Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Benefit Rate (CBR)

    CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.

    Measured: 24 weeks after first administration of Palbociclib in combination with AI / fulvestrant

Secondary outcomes (11)

  1. Number of participants with Adverse Events as assessed by CTCAE V4.0

    Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.4.03), and seriousness

    Measured: From Date of Signed informed consent until PD, assessed up to 60 months.

  2. Clinical Benefit Rate (CBR)

    CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.

    Measured: 48 weeks after first administration of Palbociclib in combination with AI / fulvestrant

  3. Progression-free Survival rate

    Follow up 4 years after LPI

    Measured: At 48 weeks (all patients) and 2 years (first-line patients only) after first administration of Palbociclib in combination with AI / fulvestrant

  4. Overall Survival rate

    Follow up 4 years after LPI

    Measured: At 48 weeks after first administration of Palbociclib in combination with AI / fulvestrant and yearly until EOS, assessed up to 60 months.

  5. Time on treatment

    Study treatment will be continued until disease progression, intolerable toxicity, death or any other reason.

    Measured: From day of first treatment until permanent discontinuation (EOT), assessed up to 60 months.

  6. Dosage

    • starting dose (mg)
    • adjusted doses (mg)

    Measured: From day of first treatment until EOT, assessed up to 60 months.

  7. Adminstration schedule

    • dates of administration

    Measured: From day of first treatment until EOT, assessed up to 60 months.

  8. Health-related quality of life (QoL)

    Health-related QoL will be assessed with the FACT-B (Functional Assessment of Cancer Therapy-Breast) questionnaire

    Measured: From date of signed informed consent until disease progression or start of next anti-cancer therapy: every 12 weeks, assessed up to 60 months.

  9. Health-related fatigue

    Fatigue will be assessed with the BFI (Brief Fatigue Inventory) questionnaire

    Measured: From date of signed informed consent until disease progression or start of next anti-cancer therapy: every 12 weeks, assessed up to 60 months.

  10. Health-related anxiety and depression

    Depression and anxiety will be assessed with the HADS-D (Hospital Anxiety and Depression Scale) questionnaire

    Measured: From date of signed informed consent until disease progression or start of next anti-cancer therapy: every 12 weeks, assessed up to 60 months.

  11. Physician's assessment of patient's overall health status and change in health status compared to previous visit

    Assessed by 2 items at each cycle/at scheduled patient visit

    Measured: From Screening until disease progression or start of next anti-cancer therapy, assessed up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2016 (estimated)
  2. Study start6 Sep 2016
  3. Primary completion15 Feb 2023
  4. Study completion15 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02894398
Sponsor's protocol ID
iOM-04318
Acronym
INGE-B
Status last verified
Mar 2023
First submitted
25 Aug 2016
Last updated
13 Mar 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib, Letrozole and Anastrozole in people with Breast Cancer and Hormone Receptor Positive Tumor, run by iOMEDICO AG at 70 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit Rate (CBR) (time frame: 24 weeks after first administration of Palbociclib in combination with AI / fulvestrant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02894398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.

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