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(vic-)trastuzumab duocarmazine for Breast Cancer (TULIP Trial)

Phase 3

Waitlist Available

Research Sponsored by Byondis B.V.

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 baseline until primary analysis data cut-off date of 31march2021

Awards & highlights

TULIP Trial Summary

This trial is testing if a new drug is better than existing treatments for breast cancer.

Eligible Conditions

Breast Cancer

TULIP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until primary analysis data cut-off date of 31march2021

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline until primary analysis data cut-off date of 31march2021

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until primary analysis data cut-off date of 31march2021 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression Free Survival

Secondary outcome measures

Investigator Assessed Progression Free Survival

Objective Response Rate

Overall Survival

+1 more

Side effects data

From 2022 Phase 3 trial • 437 Patients • NCT03262935

38%

Conjunctivitis

38%

Keratitis

33%

Fatigue

30%

Dry eye

25%

Nausea

22%

Alopecia

21%

Diarrhoea

21%

Decreased appetite

20%

Asthenia

18%

Constipation

18%

Lacrimation increased

17%

Cough

15%

Dyspnoea

14%

Anaemia

13%

Vomiting

13%

Blepharitis

11%

Headache

11%

Arthralgia

11%

Neutropenia

11%

Skin hyperpigmentation

11%

Punctate keratitis

10%

Weight decreased

Dry skin

Urinary tract infection

Dry mouth

Back pain

Vision blurred

Oedema peripheral

Pyrexia

Stomatitis

Insomnia

Dysgeusia

Pneumonitis

Abdominal pain

Dizziness

Mucosal inflammation

Periorbital oedema

Neuropathy peripheral

Pain in extremity

Platelet count decreased

Thrombocytopenia

Abdominal pain upper

Rash

Aspartate aminotransferase increased

Dyspepsia

Epistaxis

Neutrophil count decreased

Pruritus

Myalgia

Alanine aminotransferase increased

Hypokalaemia

Upper respiratory tract infection

Peripheral sensory neuropathy

Hypomagnesaemia

Palmar-plantar erythrodysaesthesia syndrome

Infusion related reaction

Wound infection

Acute respiratory failure

Pneumonia

Hypercalcaemia

100%

80%

60%

40%

20%

Study treatment Arm

(Vic-)Trastuzumab Duocarmazine

Physician's Choice

TULIP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: (vic-)trastuzumab duocarmazineExperimental Treatment1 Intervention

SYD985, every 3 weeks (Q3W)

Group II: Physician's choiceActive Control1 Intervention

Lap/Cap T/Cap T/Vino T/Eri

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

(vic-)trastuzumab duocarmazine

2017

Completed Phase 3

~440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Byondis B.V.Lead Sponsor

9 Previous Clinical Trials

680 Total Patients Enrolled

Evelyn van den Tweel, PhDStudy DirectorByondis B.V., The Netherlands

Frequently Asked Questions

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

Does (vic-)trastuzumab duocarmazine have any harmful effects for patients?

"There is both efficacy and safety data available for (vic-)trastuzumab duocarmazine, which has been well-supported in multiple rounds of clinical trials. As such, it receives a score of 3."

Answered by AI

For what purpose is (vic-)trastuzumab duocarmazine most commonly prescribed?

"Typically, refractory fallopian tube carcinoma is treated with (vic-)trastuzumab duocarmazine. This medication can also be effective for treating other conditions such as malignant neoplasms, high risk of recurrence, and monotherapy."

Answered by AI

Can you please provide a list of all research done on (vic-)trastuzumab duocarmazine?

"There are currently 613 ongoing studies investigating the efficacy of (vic-)trastuzumab duocarmazine. Of these, 192 are in Phase 3 clinical trials. The majority of research locations for this treatment are situated in Seattle, Washington; however, there are 29888 different centres running trials globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

2017. "SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03262935.