CompletedNot Applicable

An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants

Peru, Uruguay580 participantsStarted 2011-07

Plain-language summary

This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer Exclusion Criteria: * Samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study * Cancer samples that have received previous chemotherapy treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures

Timeframe: Baseline up to 30 months

Percentage of Participants With Different Phenotypes of Breast Cancer

Timeframe: Baseline up to 30 months

Percentage of Participants With Histological Sub-types of Breast Cancer

Timeframe: Baseline up to 30 months

Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups

Timeframe: Baseline up to 30 months

Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades

Timeframe: Baseline up to 30 months

Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion

Timeframe: Baseline up to 30 months

Trial details

NCT IDNCT02535026

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-12

Results submitted2017-02-24

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures

Timeframe: Baseline up to 30 months

Percentage of Participants With Different Phenotypes of Breast Cancer

Timeframe: Baseline up to 30 months

Percentage of Participants With Histological Sub-types of Breast Cancer

Timeframe: Baseline up to 30 months

Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups

Timeframe: Baseline up to 30 months

Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades

Timeframe: Baseline up to 30 months

Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion

Timeframe: Baseline up to 30 months