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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
Breast cancer must be ER-negative and HER-2 negative according to CAP/ASCO biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of less than 5
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 below
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I am 18 years old or older.
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My breast cancer is not driven by estrogen or HER2, but may be slightly progesterone receptor positive.
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My breast tumor is at least 2 cm big.
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My breast cancer is in multiple spots, all are estrogen and HER2 negative.
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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 am willing to use birth control, have a negative pregnancy test, and follow study rules.
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I have been diagnosed with invasive breast cancer.

CADENCE Trial 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

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 • 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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
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

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

Frequently Asked Questions

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

What have physicians employed Docetaxel to address in their patients?

"Docetaxel is commonly prescribed for melanoma, but also has proven efficacy in treating head cancer, soft tissue sarcoma (STS), and non-Hodgkin lymphomas."

Answered by AI

Is Docetaxel a viable option for patients due to its safety profile?

"Our internal assessment of docetaxel's safety is a 2, as there are some data that attest to its security but no studies regarding the drug's efficacy."

Answered by AI

Are there still openings for participants in this experiment?

"As the trial was last updated on April 6th 2022, this research is no longer searching for volunteers. However, there are currently 2596 studies looking to recruit patients with breast cancer and 962 studies recruiting participants for Docetaxel treatment."

Answered by AI

What is the maximum cohort size of this experiment?

"Unfortunately, this specific trial has concluded its recruitment process. It was initially announced on November 1st 2015 and the last update occurred April 6th 2022. However, if you're searching for alternatives involving breast cancer there are 2596 trials currently enrolling patients and 962 studies that utilize Docetaxel as a form of treatment."

Answered by AI
~3 spots leftby Mar 2025