← Back to Search

Chemotherapy

FDC of Pertuzumab and Trastuzumab SC for Breast Cancer (FeDeriCa Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

FeDeriCa Trial Summary

This trial is testing a new way to give two existing drugs for early breast cancer. The new way is a fixed-dose combination of pertuzumab and trastuzumab given as a subcutaneous injection. The trial will compare how well this works compared to the same drugs given the standard way.

Eligible Conditions

Breast Cancer

FeDeriCa Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8)

Secondary outcome measures

Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8)

Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Distant Recurrence-Free Interval (DRFI) Criteria

Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to EFS (Including SPNBC) Criteria

+13 more

Side effects data

From 2023 Phase 3 trial • 500 Patients • NCT03493854

70%

ALOPECIA

60%

NAUSEA

55%

DIARRHOEA

41%

ANAEMIA

30%

ASTHENIA

24%

STOMATITIS

24%

NEUTROPENIA

22%

FATIGUE

21%

CONSTIPATION

20%

HEADACHE

19%

ALANINE AMINOTRANSFERASE INCREASED

19%

MUCOSAL INFLAMMATION

19%

NEUTROPHIL COUNT DECREASED

18%

VOMITING

18%

DECREASED APPETITE

18%

ARTHRALGIA

17%

RASH

17%

MYALGIA

15%

ASPARTATE AMINOTRANSFERASE INCREASED

14%

PYREXIA

14%

DYSGEUSIA

13%

INFUSION RELATED REACTION

13%

PERIPHERAL SENSORY NEUROPATHY

13%

EPISTAXIS

13%

LEUKOPENIA

12%

NEUROPATHY PERIPHERAL

12%

WHITE BLOOD CELL COUNT DECREASED

12%

COUGH

12%

DRY SKIN

11%

INSOMNIA

10%

HOT FLUSH

10%

DYSPEPSIA

UPPER RESPIRATORY TRACT INFECTION

PROCEDURAL PAIN

DIZZINESS

OEDEMA PERIPHERAL

NASOPHARYNGITIS

PARAESTHESIA

PRURITUS

RADIATION SKIN INJURY

HYPOKALAEMIA

NAIL DISCOLOURATION

NAIL DISORDER

ABDOMINAL PAIN UPPER

EJECTION FRACTION DECREASED

PAIN IN EXTREMITY

PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME

MALAISE

ABDOMINAL PAIN

URINARY TRACT INFECTION

WEIGHT DECREASED

LACRIMATION INCREASED

ERYTHEMA

HAEMORRHOIDS

BACK PAIN

BONE PAIN

DYSPNOEA

RHINORRHOEA

DERMATITIS

FEBRILE NEUTROPENIA

DRY EYE

PARONYCHIA

SEPSIS

MASTITIS

POSTOPERATIVE WOUND INFECTION

INJECTION SITE REACTION

CARDIAC FAILURE

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy

Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy

FeDeriCa Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: FDC of Pertuzumab and Trastuzumab SC + ChemotherapyExperimental Treatment8 Interventions

Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab will be given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.

Group II: Arm A: Pertuzumab IV + Trastuzumab IV + ChemotherapyActive Control10 Interventions

Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel Q1W for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab will be given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hormone Therapy

2018

Completed Phase 3

~550

Surgery

2000

Completed Phase 3

~2550

Post-operative Radiotherapy

2018

Completed Phase 3

~500

FDC of Pertuzumab and Trastuzumab SC

2018

Completed Phase 3

~500

Docetaxel

1995

Completed Phase 4

~5620

Cyclophosphamide

1995

Completed Phase 3

~3770

Doxorubicin

2012

Completed Phase 3

~7940

Paclitaxel

2011

Completed Phase 4

~5380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,089,568 Total Patients Enrolled

160 Trials studying Breast Cancer

91,442 Patients Enrolled for Breast Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,440 Total Patients Enrolled

138 Trials studying Breast Cancer

72,096 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any research facilities in Canada testing this hypothesis?

"There are 9 enrolling patients for this trial including Royal Victoria Hospital in Barrie, Maryland Oncology Hematology in Rockville, and Northwest Medical Specialties in Lakewood. To name a few other locations, there are also medical centres in 9 other locations."

Answered by AI

Are there other existing examples of Pertuzumab and Trastuzumab SC working together in a clinical capacity?

"At this time, there are 2150 ongoing studies investigating the efficacy of FDC of Pertuzumab and Trastuzumab SC. Out of these, 501 are in Phase 3. Additionally, while many clinical trials for this medication combination are based in Seattle, Washington, there are a total of 90620 locations running these kinds of tests."

Answered by AI

What are the FDA-approved indications for Pertuzumab and Trastuzumab SC?

"FDC of Pertuzumab and Trastuzumab SC has shown efficacy in treating acute lymphoblastic leukemia (all), head, and neoplasm metastasis."

Answered by AI

How many people are chosen to participate in this research?

"This particular study has completed its recruitment drive, as the latest update on clinicaltrials.gov was from October 27th, 2022. However, there are 2370 trials for breast cancer and 2150 FDC of Pertuzumab and Trastuzumab SC actively recruiting patients."

Answered by AI

Has the FDA given their okay to Pertuzumab and Trastuzumab SC being administered together?

"FDC of Pertuzumab and Trastuzumab SC have both been studied rigorously and thus are estimated to be safe (3 on a scale from 1-3)."

Answered by AI

Are volunteers currently being accepted for this research project?

"This particular study is not actively recruiting patients at the moment. The clinical trial was first announced on June 14th, 2018 and has since been edited October 27th, 2022. If you are looking for other trials, there are 2370 studies searching for breast cancer patients and 2150 researching FDC of Pertuzumab and Trastuzumab SC that have open recruitment."

Answered by AI

Have these procedures been tested before on human subjects?

"FDC of Pertuzumab and Trastuzumab SC has a long history, with the first study being completed in 1997. 300 patients were involved in Alfacell's sponsored Phase 1 trial. After proving efficacy and safety in this initial test group, FDC of Pertuzumab and Trastuzumab SC received drug approval for Phase 3 trials. Presently, there are 2150 live studies involving this medication taking place across 83 countries and 4065 cities."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Fixed-dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection Plus Chemotherapy in Her2-positive Early Breast Cancer (federica): A Randomised, Open-label, Multicentre, Non-inferiority, Phase 3 Study

Tan, Antoinette R, Seock-Ah Im, André Mattar, Ramon Colomer, Daniil Stroyakovskii, Zbigniew Nowecki, Michelino De Laurentiis, et al.. 2021. “Fixed-dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection Plus Chemotherapy in Her2-positive Early Breast Cancer (federica): A Randomised, Open-label, Multicentre, Non-inferiority, Phase 3 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30536-2.

clinicaltrials.govStudy

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

2018. "A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03493854.