Breast NeoplasmsHerSCinNCT01959386
A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer
An observational study of Breast Neoplasms, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Trastuzumab
- How many people
- 1,006 participants
- Where
- 1 siteGermany
- Study dates
- 7 Nov 2013to 31 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants with HER2-positive early breast cancer initiated on treatment with subcutaneously administered trastuzumab.
Who may be able to join
- Histologically confirmed adenocarcinoma of the breast
- HER2-positive tumor
- Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC
Who cannot join
- Contraindications according to the Summary of Product Characteristics of Herceptin SC
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131
About this study
Official title: Clinical Practice Surveillance of the Use of Herceptin® Subcutaneous in Patients With HER2-Positive Early Breast Cancer (HerSCin)
This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Data from eligible participants will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years of follow-up.
- Conditions
- Breast Neoplasms
- Being tested
- Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herceptin
Participants will be receiving trastuzumab as part of their treatment for breast cancer according to the judgement of physician and according to the actual summary of product characteristics. The study protocol does not influence the physician's decision regarding diagnostics, therapy or frequency of medical examination during or after the treatment.
| Study group | Role | What they receive |
|---|---|---|
| HER2 Positive Breast Cancer Participants | Participants with HER2 positive tumors who are considered for treatment with trastuzumab SC according to the judgement of physician and according to the actual summary of product characteristics will be observed for a period of approximately 1 year and will be followed for an additional 2 years. Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Pathologic Complete Response (pCR) (For Participants Treated in Neo-Adjuvant Setting), According to Response Evaluation Criteria in Solid Tumor (RECIST), or Modified RECIST, or Cheson Criteria (As per Center Practice)
Measured: Baseline up to approximately 3 years (assessed according to routine center practice)
Percentage of Participants Who Were Alive and Disease Free at Year 2 (For Participants Treated in the Adjuvant Setting), According to RECIST, or Modified RECIST, or Cheson Criteria (As per Center Practice)
Measured: Year 2
Secondary outcomes (7)
Percentage of Participants with Adverse Events
Measured: Baseline up to approximately 3 years
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Scores
Measured: Baseline, every 12 weeks up to Year 1
European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score
Measured: Baseline, every 12 weeks up to Year 1
Mean Trastuzumab Dose
Measured: Baseline up to Year 1
Duration of Trastuzumab Treatment
Measured: Baseline up to Year 1
Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption
Measured: Baseline up to Year 1
Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)
Measured: Baseline up to Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study start7 Nov 2013
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959386
- Sponsor's protocol ID
- ML28759
- Acronym
- HerSCin
- Status last verified
- Mar 2020
- First submitted
- 8 Oct 2013
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Practice Surveillance of the Use of Herceptin® Subcutaneous in Patients With HER2-Positive Early Breast Cancer (HerSCin)
- ClinicalTrials.gov ID
- NCT01959386
- Acronym / sponsor ID
- HerSCin / ML28759
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2013 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Data from eligible participants will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 Positive Breast Cancer Participants | – | Drug: TrastuzumabParticipants with HER2 positive tumors who are considered for treatment with trastuzumab SC according to the judgement of physician and according to the actual summary of product characteristics will be observed for a period of approximately 1 year and will be followed for an additional 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with HER2-positive early breast cancer initiated on treatment with subcutaneously administered trastuzumab.
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma of the breast
- HER2-positive tumor
- Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC
Key exclusion criteria (2 listed)
- Contraindications according to the Summary of Product Characteristics of Herceptin SC
- Pregnant and breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAlso: HerceptinParticipants will be receiving trastuzumab as part of their treatment for breast cancer according to the judgement of physician and according to the actual summary of product characteristics. The study protocol does not influence the physician's decision regarding diagnostics, therapy or frequency of medical examination during or after the treatment. | Drug | HER2 Positive Breast Cancer Participants |
Primary outcome
Percentage of Participants With Pathologic Complete Response (pCR) (For Participants Treated in Neo-Adjuvant Setting), According to Response Evaluation Criteria in Solid Tumor (RECIST), or Modified RECIST, or Cheson Criteria (As per Center Practice)
Time frame: Baseline up to approximately 3 years (assessed according to routine center practice)
Percentage of Participants Who Were Alive and Disease Free at Year 2 (For Participants Treated in the Adjuvant Setting), According to RECIST, or Modified RECIST, or Cheson Criteria (As per Center Practice)
Time frame: Year 2
7 secondary outcomes
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 3 years
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Scores
Time frame: Baseline, every 12 weeks up to Year 1
European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score
Time frame: Baseline, every 12 weeks up to Year 1
Mean Trastuzumab Dose
Time frame: Baseline up to Year 1
Duration of Trastuzumab Treatment
Time frame: Baseline up to Year 1
Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption
Time frame: Baseline up to Year 1
Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)
Time frame: Baseline up to Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Hoffmann-La Roche at 1 site 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 3 inclusion and 2 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Percentage of Participants With Pathologic Complete Response (pCR) (For Participants Treated in Neo-Adjuvant Setting), According to Response Evaluation Criteria in Solid Tumor (RECIST), or Modified RECIST, or Cheson Criteria (As per Center Practice) (time frame: Baseline up to approximately 3 years (assessed according to routine center practice)). 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?
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 3 Mar 2020.