185 Participants Needed

Chemotherapy Response Prediction for Breast Cancer

(RESPONSE Trial)

Recruiting at 2 trial locations
AP
KO
MR
Overseen ByMaria Rodriguez
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on treatments for breast cancer or have a history of cardiac disease, you may need to discuss this with the trial team.

What evidence supports the effectiveness of the drugs used in the Chemotherapy Response Prediction for Breast Cancer trial?

Research shows that combinations of drugs like doxorubicin and docetaxel have higher response rates and longer time to disease progression in breast cancer treatment compared to some other drug combinations. Additionally, studies indicate that combining trastuzumab with paclitaxel or doxorubicin and cyclophosphamide can lead to better outcomes in terms of response rate and disease progression.12345

Is carboplatin generally safe for use in humans?

Carboplatin is generally considered safe for use in humans, with less kidney toxicity compared to similar drugs like cisplatin. However, it can cause side effects such as nausea, vomiting, and blood-related issues like low white blood cell counts, which can increase infection risk. Some people may also experience allergic reactions, especially after multiple treatment cycles.678910

How does this drug combination for breast cancer differ from other treatments?

This drug combination for breast cancer is unique because it includes a mix of chemotherapy agents like carboplatin, cyclophosphamide, doxorubicin, paclitaxel, pertuzumab, and trastuzumab, which are known for their effectiveness in different settings. Paclitaxel, in particular, has shown high activity in breast cancer treatment, and the combination aims to enhance response rates while potentially reducing toxicity compared to using these drugs individually.27111213

Research Team

Dr. Mothaffar Rimawi, MD | Houston, TX ...

Mothaffar Rimawi, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older and can legally consent to treatment.
Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal
Participation in a concurrent clinical trial is permitted, with Principal Investigator approval
See 5 more

Exclusion Criteria

Participants who are pregnant or lactating
I don't have any health conditions that would stop me from receiving or following up on treatment.
My condition is confirmed to be at Stage IV.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive chemotherapy prior to surgery, including Paclitaxel and other drugs depending on the breast cancer subtype

16 weeks
8 cycles of treatment

Surgery

Surgical procedure to assess pathologic response and remove any remaining tumor

1 week

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

  • Carboplatin
  • Cyclophosphamide
  • Doxorubicin
  • Paclitaxel
  • Pembrolizumab
  • Pertuzumab
  • Pertuzumab/Trastuzumab/Hyaluronidase-zzxf
  • Trastuzumab
Trial OverviewThe 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.
Participant Groups
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)

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
🇪🇺
Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
🇨🇦
Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Breast Care Center

Lead Sponsor

Trials
16
Recruited
750+

Findings from Research

Hormonal therapy is the preferred initial treatment for Stage IV breast cancer due to its lower toxicity, but response rates decline with each progression, making chemotherapy a necessary option for hormone-resistant cases.
Doxorubicin and paclitaxel are effective chemotherapy agents, with doxorubicin showing high response rates but potential cardiomyopathy at high cumulative doses, while increasing dose intensity can help overcome drug resistance.
Salvage chemotherapy of breast cancer.Norton, L.[2007]
In a dose-finding study, the combination of docetaxel and cisplatin showed a promising response rate of 60% in patients with metastatic breast cancer, indicating its potential as an effective first-line treatment option.
Carboplatin, due to its lower toxicity, may also be a viable alternative in combination with taxanes, while vinorelbine combined with docetaxel achieved a response rate of 59% in patients previously treated with anthracyclines.
Nonanthracycline containing docetaxel-based combinations in metastatic breast cancer.Crown, J.[2019]
The combination of docetaxel and doxorubicin (TAC) has shown significantly higher response rates in advanced breast cancer treatment compared to traditional regimens, with a response rate of 54% versus 42% for the 5-fluorouracil/doxorubicin/cyclophosphamide regimen, based on a study involving 484 patients.
While TAC treatment was associated with a higher incidence of febrile neutropenia, it did not increase the risk of serious infections or cardiotoxicity, indicating a favorable safety profile for this combination therapy.
Docetaxel in the treatment of breast cancer: an update on recent studies.Nabholtz, JM., Reese, DM., Lindsay, MA., et al.[2019]

References

Salvage chemotherapy of breast cancer. [2007]
Nonanthracycline containing docetaxel-based combinations in metastatic breast cancer. [2019]
Docetaxel in the treatment of breast cancer: an update on recent studies. [2019]
New developments in chemotherapy of advanced breast cancer. [2016]
BCIRG 001 molecular analysis: prognostic factors in node-positive breast cancer patients receiving adjuvant chemotherapy. [2018]
Carboplatin: a very active new cisplatin analog in the treatment of small cell lung cancer. [2013]
PPAR signaling pathway may be an important predictor of breast cancer response to neoadjuvant chemotherapy. [2022]
Hypersensitivity and cross-reactivity to cisplatin and analogues. [2018]
Phase II study of carboplatin in advanced breast cancer: preliminary results. [2013]
Risk Factors of Hypersensitivity to Carboplatin in Patients with Gynecologic Malignancies. [2020]
[Chemosensitivity test for 170 human breast carcinoma samples]. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
Paclitaxel doublets in metastatic breast cancer: Eastern Cooperative Oncology Group and Hoosier Oncology Group Studies. [2015]
Comparative chemosensitivity profiles in three human breast cancer cell lines with the ATP-cell viability assay. [2018]