Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
Awards & highlights
CADENCE Trial 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.Check my eligibility
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.See study design
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.
CADENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My breast tumor is at least 2 cm big.
Select...
I have a breast lump at least 2cm big, confirmed by imaging.
Select...
My blood tests show normal organ function and healthy blood cell counts.
Select...
I have been diagnosed with invasive breast cancer.
CADENCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Complete Response
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
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
CADENCE 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
Docetaxel
1995
Completed Phase 4
~5620
Carboplatin
2014
Completed Phase 3
~6670
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My breast cancer is in multiple spots, all are estrogen and HER2 negative.I have a breast lump at least 2cm big, confirmed by imaging.My blood tests show normal organ function and healthy blood cell counts.I have not had cancer, except for certain skin cancers or cervical pre-cancer, in the last 5 years.My condition is inflammatory breast cancer.My cancer is at stage IV.I am allergic to medications similar to docetaxel or carboplatin.I have tested positive for HIV, HCV, or HBV.I have cancer in both breasts or cancer on one side and non-invasive cancer on the other.I am 18 years old or older.My breast cancer is not driven by estrogen or HER2, but may be slightly progesterone receptor positive.My breast tumor is at least 2 cm big.I am willing to use birth control, have a negative pregnancy test, and follow study rules.I have been diagnosed with invasive breast cancer.I have not had any breast cancer treatment in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Docetaxel/Carboplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger