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Alkylating agents

Chemotherapy Response Prediction for Breast Cancer (RESPONSE Trial)

Q: Are there any positions available in this trial for new patients?

<p>Unfortunately, this particular trial is no longer recruiting patients. Although the last update was on May 15th, 2022, it was originally posted on June 15th of the same year. There are plenty of other trials, however; 7278 to be exact.</p>

Q: How many volunteers are taking part in this experiment?

<p>Unfortunately, this particular study is not currently looking for more participants. Although, it's worth mentioning that there are 5074 other trials related to triple negative breast neoplasms and 2204 trials concerning <a href="https://www.withpower.com/clinical-trials/triple-negative-breast-cancer">Triple negative breast cancer</a> (for tumors > 5 cm) that are actively recruiting patients right now.</p>

Phase 2

Recruiting

Led By Mothaffar Rimawi, MD

Research Sponsored by Baylor Breast Care Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed, invasive breast cancer. Tumor may be triple negative, HER2-positive, or high-risk estrogen receptor positive

Tumors must be at least 2 cm by clinical exam or ultrasound

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

RESPONSE Trial Summary

This trial will study whether the amount a tumor shrinks before surgery can predict how much of the tumor will remain after surgery.

Who is the study for?

This trial is for adults with invasive breast cancer that's at least 2 cm large, including triple negative, HER2-positive, or high-risk estrogen receptor positive types. Participants must be able to consent and use non-hormonal contraception if applicable. They should have good organ function and heart health but no severe diseases, HIV/hepatitis infections, recent other cancers, psychiatric issues preventing study compliance, prior breast cancer treatments or surgeries.Check my eligibility

What is being tested?

The study tests whether the shrinkage of a tumor from chemotherapy before surgery can predict how much tumor remains at surgery time. It involves drugs like Carboplatin and Trastuzumab among others in patients with early-stage breast cancer to see if physical changes correlate with surgical findings.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medications; heart problems due to Doxorubicin; blood disorders from Carboplatin; nerve damage or joint pain from Paclitaxel; immune-related issues from Pembrolizumab; and general symptoms like nausea, fatigue or infection risk.

RESPONSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is confirmed and may be triple negative, HER2-positive, or high-risk estrogen receptor positive.

Select...

My tumor is at least 2 cm in size.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My organs are functioning well.

RESPONSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Clinical Tumor Measurement vs. Pathologic Response

Secondary outcome measures

Pathologic Complete Response Rate in each Breast Cancer Subtype

Pharmacotherapy

Other outcome measures

Change in circulating tumor DNA (ctDNA) levels from baseline to surgery

RESPONSE Trial Design

4Treatment groups

Active Control

Group I: Triple Negative Breast Cancer (for tumors > 5 cm)Active Control5 Interventions

Paclitaxel IV plus carboplatin IV (+/- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+/- pembrolizumab IV) (4 cycles total)

Group II: HER2-Positive Breast CancerActive Control6 Interventions

Paclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total)

Group III: Triple Negative Breast Cancer (for tumors < 5 cm)Active Control3 Interventions

Paclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)

Group IV: Hormone Receptor Positive Breast CancerActive Control3 Interventions

Paclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor Breast Care CenterLead Sponsor

15 Previous Clinical Trials

568 Total Patients Enrolled

11 Trials studying Breast Cancer

501 Patients Enrolled for Breast Cancer

Mothaffar Rimawi, MDPrincipal InvestigatorBaylor College of Medicine

14 Previous Clinical Trials

752 Total Patients Enrolled

10 Trials studying Breast Cancer

649 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05020860 — Phase 2

Breast Cancer Research Study Groups: Triple Negative Breast Cancer (for tumors > 5 cm), HER2-Positive Breast Cancer, Triple Negative Breast Cancer (for tumors < 5 cm), Hormone Receptor Positive Breast Cancer

Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05020860 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020860 — Phase 2

Frequently Asked Questions

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

Are there any positions available in this trial for new patients?

"Unfortunately, this particular trial is no longer recruiting patients. Although the last update was on May 15th, 2022, it was originally posted on June 15th of the same year. There are plenty of other trials, however; 7278 to be exact."

Answered by AI

How many volunteers are taking part in this experiment?

"Unfortunately, this particular study is not currently looking for more participants. Although, it's worth mentioning that there are 5074 other trials related to triple negative breast neoplasms and 2204 trials concerning Triple negative breast cancer (for tumors > 5 cm) that are actively recruiting patients right now."

Answered by AI

Is this a groundbreaking clinical trial?

"Since 1997, there have been 2204 ongoing studies and 2978 completed trials for Triple negative breast cancer (for tumors > 5 cm) across 87 countries and 4024 cities."

Answered by AI

What is the most common treatment for Triple Negative Breast Cancer (for tumors > 5 cm)?

"While most often used to treat acute lymphoblastic leukemia, triple negative breast cancer can also help patients dealing with neoplasm metastasis, cyclophosphamide, lymphoma, and non-hodgkin."

Answered by AI

Does the FDA condone Triple Negative Breast Cancer treatments for patients with tumors larger than 5 cm?

"For Triple negative breast cancer (for tumors > 5 cm), our team has given it a score of 2. This is because while there is some data indicating that the intervention might be safe, at this stage there is no evidence to support efficacy."

Answered by AI

Are there any other documented cases of research done on Triple Negative Breast Cancer (for tumors larger than 5 cm)?

"2204 studies are currently underway to research Triple negative breast cancer (for tumors > 5 cm), with 507 of them in the critical Phase 3. Most of these investigations into Triple Negative Breast Cancer (for tumors > 5 cm) are based in Seattle, Washington, but there are 95200 locations running clinical trials for Triple Negative Breast Cancer (for tumors > 5 cm)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Mothaffar Rimawi 2023. "Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020860.

All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer