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Carboplatin + Docetaxel for Breast Cancer (CADENCE Trial)

Phase 2
Waitlist Available
Led By Mothaffar Rimawi, MD
Research Sponsored by Mothaffar Rimawi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be 18 years of age or older
Primary breast tumor size must be at least 2 cm in one dimension by clinical or radiographic exam
Must not have
Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Inflammatory breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests whether combining two cancer drugs is effective in treating patients with a certain type of breast cancer.

Who is the study for?
This trial is for adults with invasive triple negative breast cancer, where the tumor is at least 2 cm. They must have normal organ and bone marrow function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and have no severe illnesses that could interfere with the study. Prior systemic therapy for breast cancer within 5 years disqualifies them.
What is being tested?
The effectiveness of combining two chemotherapy drugs, Docetaxel and Carboplatin, is being tested on patients with triple negative breast cancer before surgery (neoadjuvant treatment). The goal is to see if this combination helps shrink tumors effectively.
What are the potential side effects?
Docetaxel and Carboplatin can cause side effects like low blood cell counts leading to increased infection risk or bleeding problems, fatigue, hair loss, nausea/vomiting, allergic reactions and possible damage to nerves causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My breast tumor is at least 2 cm big.
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I have a breast lump at least 2cm big, confirmed by imaging.
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My blood tests show normal organ function and healthy blood cell counts.
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I have been diagnosed with invasive breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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My condition is inflammatory breast cancer.
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My cancer is at stage IV.
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I am allergic to medications similar to docetaxel or carboplatin.
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I have tested positive for HIV, HCV, or HBV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of definitive surgery (approximately 4-5 months after beginning chemotherapy) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathologic Complete Response

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Docetaxel/CarboplatinExperimental Treatment2 Interventions
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Docetaxel
1995
Completed Phase 4
~6550

Find a Location

Who is running the clinical trial?

Mothaffar RimawiLead Sponsor
5 Previous Clinical Trials
375 Total Patients Enrolled
4 Trials studying Breast Cancer
335 Patients Enrolled for Breast Cancer
Mothaffar Rimawi, MDPrincipal InvestigatorBaylor College of Medicine
14 Previous Clinical Trials
912 Total Patients Enrolled
10 Trials studying Breast Cancer
809 Patients Enrolled for Breast Cancer

Media Library

Docetaxel Clinical Trial Eligibility Overview. Trial Name: NCT02547987 — Phase 2
Breast Cancer Research Study Groups: Docetaxel/Carboplatin
Breast Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT02547987 — Phase 2
Docetaxel 2023 Treatment Timeline for Medical Study. Trial Name: NCT02547987 — Phase 2
~2 spots leftby Nov 2025
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