AzTrials
AzTrials

Advanced Breast CancerKATIANCT03829306

Unraveling KAdcyla Resistance In Human Epidermal Growth Factor Receptor 2(HER2) Positive Advanced Breast Cancer (KATIA)

An observational study of Advanced Breast Cancer, run by Spanish Breast Cancer Research Group at 10 sites in Spain.

Completed

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

Official record
Search all trials

Trial summary

The study aim is to perform a comprehensive and integrated characterization of mechanisms of primary and acquired resistance to Kadcyla in a prospective cohort of progressive/recurrent HER2-positive breast cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
How many people
32 participants
Where
10 sitesSpain
Study dates
12 Jun 2018to 21 Jun 2022
Phase
Observational
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
  • All sexes
  • Adult, Older adult

Study population: The target population for inclusion in this study is HER2-positive Advanced Breast Cancer patients who are planned to be treated with Kadcyla whithin the approved indication in Spain.

Who may be able to join

  • Patients are eligible to be included in the study only if they meet all of the following criteria and according to the corresponding Summary of Product Characteristics (SmPC):
  • The patient has signed and dated the informed consent form (ICF) and it has been obtained before conducting any study specific procedure.
  • Female or male patients ≥ 18 years of age on day of signing informed consent.
  • Documented HER2-positive breast cancer based on local laboratory determination (preferably assessed on the most recent tumor biopsy available).
  • Patients with evidence of advanced disease not amenable to resection or radiation therapy with curative intent who are planned to receive Kadcyla within the approved indication in Spain: as a single agent for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
  • Received prior therapy for locally advanced or metastatic disease, or
Show all 14Show fewer
  • Developed disease recurrence during or within six months of completing adjuvant therapy
  • Presence of measurable disease according to RECIST 1.1 for assessment of tumor response.
  • Availability of tumor tissue sample from the primary tumor and/or the recurrence/metastatic site. Effort will be made to obtain a biopsy from a metastatic site in easily accessible tissues.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  • Patient must have a life expectancy ≥16 weeks.
  • Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI-CTCAE v5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).
  • Negative serum pregnancy test result for women of childbearing potential and for women who have experienced menopause onset < 12 months prior to study entry.
  • Willingness and ability to comply with the protocol for the duration of the study including tumor and blood sample collection and undergoing the standard medical practice visits.

Who cannot join

  • Patients will be excluded from the study if they meet any of the following criteria and according to the corresponding Summary of Product Characteristics (SmPC):
  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons), within 3 weeks prior to study entry (or a longer period depending on the defined characteristics of the agents used).
  • Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with brain metastases may be eligible for the study only if more than 4 weeks elapsed from treatment completion for these metastases (including radiation and/or surgery) and are clinically stable at the time of study entry.
  • Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the period of Kadcyla administration.
  • To present contraindications for the treatment with Kadcyla according to the corresponding Summary of Product Characteristics (SmPC).
  • Known hypersensitivity to Kadcyla, excipients and/or murine proteins.
Show all 12Show fewer
  • Pregnancy or breast feeding women.
  • Persistent toxicities ( NCI-CTCAE v 5.0 grade 2) caused by previous cancer therapy (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Known active liver disease, for example, due to hepatitis viruses B (HBV), hepatitis viruses C (HCV), autoimmune hepatic disorders, or sclerosing cholangitis.
  • History of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix and colon. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or Kadcyla 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital Universitario Santa Creu i Sant Pau

    Barcelona, 08025

  • ICO L´Hospitalet

    Barcelona, 08908

  • Hospital Clínico Universitario "Virgen de la Arrixaca"

    El Palmar, Murcia, 30120

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hopsital Clínico San Carlos

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Clínico Universitario de Valencia

    Valencia

Other trials in Spain

About this study

Official title: "Unraveling KAdcyla (Trastuzumab Emtansine; T-DM1) Resistance In HER2-positive Advanced Breast Cancer (ABC): a Prospective GEICAM Study"

The study aim is to perform a comprehensive and integrated characterization of mechanisms of primary and acquired resistance to Kadcyla in a prospective cohort of progressive/recurrent HER2-positive breast cancer patients.

Read the detailed description

This exploratory project is a prospective and multicenter study designed to evaluate the mechanisms of primary and acquired resistance to Kadcyla in a cohort of 50 progressive/recurrent HER2+ BC patients planned to be treated with Kadcyla within the approved indication in Spain.

This study will collect high quality molecular data derived from the analysis of serial biological samples (primary tumor and/or metastatic tissue, plasma, serum and whole blood samples), together with annotated clinical follow up, to reach a better understanding of the biological events that drive breast cancer progression and response/resistance to Kadcyla in ABC patients.

Keywords
HER2-positive

What is being measured

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

  1. Genomic alterations on tumor samples with Objective Response (OR) to Kadcyla

    Genomic alterations at baseline Formalin-Fixed Paraffin-Embedded (FFPE) tumor samples (primary tumor or metastatic sample) will be analysed by F-One. This test provides information about genomic alterations (base substitutions, insertions/deletions, copy number variations and rearrangements) in 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer (https://foundationone.com/docs/FoundationOne).

    OR (complete response plus partial response) will be measured in tumor assessments performed approximately every 3 cycles, based on the investigator assessment according to the standard institutional guidelines using RECIST version 1.1.

    Measured: Estimated median of 12 months (until disease progression is confirmed)

  2. Tumor-specific mutation in plasma samples with OR to Kadcyla

    Tumor-specific mutation identification will be measured by the test Foundation ACT (F-ACT) on plasma samples collected at baseline and at progression.This test probes 62 cancer-related genes across the 4 classes of genomic alterations (https://www.foundationmedicine.com/genomic-testing/foundation-act). OR (complete response plus partial response) will be measured in tumor assessments performed approximately every 3 cycles, based on the investigator assessment according to the standard institutional guidelines using RECIST version 1.1.

    Measured: Estimated median of 12 months (until disease progression is confirmed)

Secondary outcomes (7)

  1. Genomic alterations on tumor samples with progression-free survival (PFS)

    Genomic alterations at baseline FFPE tumor samples (primary tumor or metastatic sample) will be analysed by F-One. This test provides information about genomic alterations (base substitutions, insertions/deletions, copy number variations and rearrangements) in 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer (http://foundationone.com/docs/FoundationOne).

    Progression-free survival (PFS) to Kadcyla and subsequent treatment lines based on the investigator's assessment at 6 and 12 months.

    Measured: Estimated median of 12 months (until disease progression is confirmed)

  2. Tumor-specific mutation in plasma samples with progression-free survival (PFS)

    Tumor-specific mutation in plasma samples with OR Tumor-specific mutation identification will be measured by the test Foundation ACT (F-ACT) on plasma samples collected at baseline and at progression.

    Progression-free survival (PFS) to Kadcyla and subsequent treatment lines based on the investigator's assessment

    Measured: Estimated median of 12 months (until disease progression is confirmed)

  3. Genomic alterations on tumor samples with Progression-free survival

    Genomic alterations at baseline FFPE tumor samples (primary tumor or metastatic sample) will be analysed by F-One. This test provides information about genomic alterations (base substitutions, insertions/deletions, copy number variations and rearrangements) in 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer (http://foundationone.com/docs/FoundationOne).

    Progression-free survival (PFS) to Kadcyla and subsequent treatment lines based on the investigator's assessment

    Measured: Estimated median of 12 months (until disease progression is confirmed)

  4. Genomic alterations on tumor samples with Time to Progression (TTP)

    Genomic alterations at baseline FFPE tumor samples (primary tumor or metastatic sample) will be analysed by F-One. This test provides information about genomic alterations (base substitutions, insertions/deletions, copy number variations and rearrangements) in 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer (http://foundationone.com/docs/FoundationOne).

    Time to progression (TTP) to Kadcyla and subsequent treatment lines based on the investigator's assessment.

    Measured: Estimated median of 12 months (until disease progression is confirmed)

  5. Tumor-specific mutation in plasma samples with Progression-free survival

    Tumor-specific mutation identification will be measured by the test Foundation ACT (F-ACT) on plasma samples collected at baseline and at progression.

    Progression-free survival (PFS) to Kadcyla and subsequent treatment lines based on the investigator's assessment

    Measured: Estimated median of 12 months (until disease progression is confirmed)

  6. Tumor-specific mutation in plasma samples Time to Progression (TTP)

    Tumor-specific mutation identification will be measured by the test Foundation ACT (F-ACT) on plasma samples collected at baseline and at progression.

    Time to progression (TTP) to Kadcyla and subsequent treatment lines based on the investigator's assessment.

    Measured: Estimated median of 12 months (until disease progression is confirmed)

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Adverse events will be assessed by standard clinical and laboratory tests (hematology, serum chemistry). Adverse events grade will be defined by the NCI-CTCAE v5.0. Dose/schedule modifications will be also recorded.

    Measured: Through study treatment, estimated median of 12 months

Timeline

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

  1. First posted4 Feb 2019
  2. Study start12 Jun 2018
  3. Primary completion21 Jun 2022
  4. Study completion21 Jun 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829306
Sponsor's protocol ID
GEICAM/2017-04
Acronym
KATIA
Status last verified
Jan 2023
First submitted
10 Jan 2019
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Breast Cancer, run by Spanish Breast Cancer Research Group at 10 sites in Spain.

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 14 inclusion and 12 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. 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.

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?

Genomic alterations on tumor samples with Objective Response (OR) to Kadcyla (time frame: Estimated median of 12 months (until disease progression is confirmed)). The study lists 2 primary outcomes in all. 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 NCT03829306.

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 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in