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Alkylating agents

Chemotherapy Tolerance in Elderly Patients with Breast Cancer

Phase 1
Waitlist Available
Led By Rachel Freedman, MD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-metastatic, invasive breast cancer
Participants must have histologically or cytologically confirmed breast cancer that is human epidermal growth factor receptor 2 negative (HER2-negative) per the most recent 2018 ASCO CAP guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying how well chemotherapy is tolerated in a group of patients age 70.

Who is the study for?
This trial is for men and women aged 70 or older with non-metastatic, invasive breast cancer that's HER2-negative. They must be fit enough for chemotherapy, willing to complete surveys, and have not received chemo for the current cancer or certain drugs in the last 2 years.Check my eligibility
What is being tested?
The 'ADVANCE' pilot study tests how well patients age 70 tolerate chemotherapy before or after surgery. It involves Paclitaxel, Cyclophosphamide, and Carboplatin as potential treatments without concurrent surgeries or other therapies.See study design
What are the potential side effects?
Chemotherapy with Paclitaxel, Cyclophosphamide, and Carboplatin can cause side effects like nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, allergic reactions and possible damage to organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer has not spread to distant parts of my body.
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My breast cancer is confirmed to be HER2-negative.
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I am 70 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Toxicity and receipt of planned therapy (feasibility)
Secondary outcome measures
Adverse events
Consequences of toxicity or disease events
Invasive disease-free survival
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cyclophosphamide + PaclitaxelExperimental Treatment2 Interventions
Paclitaxel will be administered intravenously 3 times per cycle Cyclophosphamide will be administered once per cycle
Group II: Carboplatin + PaclitaxelExperimental Treatment2 Interventions
Paclitaxel will be administered intravenously 3 times per cycle Carboplatin will be administered intravenously 3 times per cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,831 Total Patients Enrolled
141 Trials studying Breast Cancer
22,576 Patients Enrolled for Breast Cancer
Mayo ClinicOTHER
3,205 Previous Clinical Trials
3,766,743 Total Patients Enrolled
82 Trials studying Breast Cancer
13,871 Patients Enrolled for Breast Cancer
Rachel Freedman, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
77 Total Patients Enrolled
1 Trials studying Breast Cancer
45 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03858322 — Phase 1
Breast Cancer Research Study Groups: Carboplatin + Paclitaxel, Cyclophosphamide + Paclitaxel
Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03858322 — Phase 1
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03858322 — Phase 1

Frequently Asked Questions

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

What is the current intake for this research trial?

"Currently, this clinical trial is not enrolling new patients. As of January 28th 2022, the study has been suspended for recruitment purposes and was initially posted on March 21st 2019. For those interested in other studies, 2600 trials recruiting breast cancer patients and 1876 Paclitaxel research opportunities are available."

Answered by AI

To what conditions is Paclitaxel generally applied?

"The common medical care for non-Hodgkin's lymphoma is Paclitaxel, an effective therapy also used to treat initial leukemia cases and locally advanced lung cancer."

Answered by AI

Are there any openings for participants in this trial?

"Per information found on clinicaltrials.gov, this clinical trial is not currently recruiting patients. The listing was initially published March 21st 2019 and had its latest update January 28th 2022; however, there are presently 4476 other medical trials that accept candidates."

Answered by AI

Has Paclitaxel been employed in any other medical research endeavors?

"Since its debut in 1997 at City of Hope Comprehensive Cancer Center, paclitaxel has been featured in 2497 clinical trials. At present, 1876 experiments are actively seeking participants; many of these studies being conducted out of Boston and California."

Answered by AI

In what areas are the experiments of this study being conducted?

"This clinical trial is being conducted at 6 sites across the United States, such as Brigham and Women's Hospital in Boston, City of Hope National Medical Center in Duarte, Novant Health Oncology Specialists in Winston-Salem. There are also other locales hosting this medical research."

Answered by AI

What hazardous risks are associated with Paclitaxel treatments?

"Paclitaxel is only supported by minimal data, so our team gave it a rating of 1 out of 3 in terms of safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
'ADVANCE' (A Pilot Trial)
Rachel Freedman, MD, MPH 2019. "'ADVANCE' (A Pilot Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03858322.
~7 spots leftby Apr 2025
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