Trials Sponsors Conditions Drugs Pricing

Conditions

Mammary Cancer

Outcome Measures

Primary Outcomes (1)

To estimate the loco-regional invasive disease-free survival of patients who achieve a complete response
To estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery. 3-years loco-regional invasive disease-free survival rate is defined as time from the first date of no disease (i.e., date of stereotaxic guided biopsy) to loco-regional recurrence. Loco-regional recurrence is defined as recurrence of breast cancer in the same breast parenchyma as the original primary lesion, the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast.
3 years

Secondary Outcomes (7)

To estimate the disease-free survival at 3years of patients who achieve a complete response based on imaging and a stereotaxic guided biopsy and omit loco-regional surgery following neoadjuvant chemotherapy and dual HER2 blockade.
3 years
To estimate the disease-free survival at 5 years of patients who achieve a complete response based on imaging and a stereotaxic guided biopsy and omit loco-regional surgery following neoadjuvant chemotherapy and dual HER2 blockade.
5 years
To estimate the disease-free survival at 3years of patients who do not achieve a complete response based on imaging following neoadjuvant chemotherapy and dual HER2 blockade
3 years
To estimate the disease-free survival at 5 years of patients who do not achieve a complete response based on imaging following neoadjuvant chemotherapy and dual HER2 blockade
5 years
To compare the cost in patients with and without breast cancer surgery, not only direct cost for hospitals/public health system, but also indirect cost for public system
5 years

Study Arms (1)

Study treatment

EXPERIMENTAL

Drug: Pertuzumab and trastuzumab FDC subcutaneousDrug: PaclitaxelDrug: TDM1Drug: Endocrine therapyProcedure: Omission surgery

Interventions

Pertuzumab and trastuzumab FDC subcutaneousDrug

Pertuzumab and trastuzumab FDC subcutaneous, A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg; day 1 of each 3 week cycle during 5 neoadjuvant cycles and 13 adjuvant cycles if complete response

Study treatment

PaclitaxelDrug

80 mg/m2, day 1,8,15 of each 3 week cycle during 4 cycles

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Pertuzumab and trastuzumab FDC subcutaneous
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age40 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer.
A participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

Sponsors & Collaborators

Fundacion Clinic per a la Recerca Biomédica
Othercollaborator
David Garcia Cinca
Otherlead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Aleix PrattsCONTACT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumabPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, Cyclic

Central Study Contacts

Nuria Chic, MD

CONTACT

CHIC@clinic.cat

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Clinical Trial Manager

Study Record Dates

First Submitted

February 14, 2020

First Posted

March 10, 2020

Study Start

June 15, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

July 15, 2027

Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti- HER2-based Neoadjuvant Therapy (ELPIS Trial)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Study treatment

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Study treatment

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations