Carboplatin + Docetaxel for Breast Cancer

(CADENCE Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mothaffar Rimawi

Must not be taking: Investigational agents

Disqualifiers: Prior systemic therapy, Stage IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving any investigational agents, you would not be eligible to participate.

What data supports the effectiveness of the drug combination Carboplatin and Docetaxel for breast cancer?

Research shows that the combination of Docetaxel and Carboplatin has been effective in treating non-small cell lung cancer, with response rates up to 67% and manageable side effects. This suggests potential effectiveness for breast cancer, as both drugs are active in various cancers. ^{1 2 3 4 5}

What safety data exists for the combination of Carboplatin and Docetaxel in humans?

The combination of Carboplatin and Docetaxel has been studied in humans for conditions like ovarian and lung cancer. Common side effects include neutropenia (low white blood cell count), which is dose-limiting, and hypersensitivity reactions. Neurotoxicity (nerve damage) is less common, and the treatment is generally well-tolerated with manageable side effects. ^{5 6 7 8 9}

How is the drug combination of carboplatin and docetaxel unique for treating breast cancer?

The combination of carboplatin and docetaxel is unique for treating breast cancer because it offers a non-anthracycline option, which can reduce the risk of certain side effects associated with anthracyclines like doxorubicin. This combination is also noted for its lower toxicity compared to other platinum-based treatments, making it a promising first-line therapy for metastatic breast cancer. ^{1 3 4 5 10}

Research Team

Mothaffar Rimawi, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Currently receiving any other investigational agents

I have not had cancer, except for certain skin cancers or cervical pre-cancer, in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant docetaxel and carboplatin for 6 cycles, each cycle lasting 21 days

18 weeks

6 visits (in-person, every 3 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessment of pathologic complete response at the time of surgery

4-5 months

Treatment Details

Interventions

• Carboplatin
• Docetaxel

Trial Overview 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.

Participant Groups

Group I: Docetaxel/Carboplatin Experimental Treatment 2 Interventions

Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles

Who Is Running the Clinical Trial?

Mothaffar Rimawi

Lead Sponsor

Trials

6

Recruited

400+

Findings from Research

The combination of docetaxel and cisplatin showed a response rate of 32% and a median survival of 11.5 months in patients with advanced non-small-cell lung cancer (NSCLC), indicating its efficacy as a treatment option.

When combined with carboplatin, docetaxel demonstrated an improved response rate of 36% and a longer median survival of 13.9 months, suggesting that this combination may have a better safety profile and therapeutic index compared to the cisplatin combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel in combination with platinum compounds for non small-cell lung cancer. Belani, CP.[2019]

The combination of docetaxel and cisplatin is effective for treating stage IIIB/IV non-small cell lung cancer, showing response rates between 32% and 48% and median survival times of 8 to 13 months across four phase II trials.

Docetaxel combined with carboplatin also demonstrated promising results, with a 48% response rate in a small group of 27 patients, indicating that these combinations are well tolerated and may improve outcomes if used earlier in the disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in combination with platinum-based regimens in non-small cell lung cancer: results and future developments. Belani, CP.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonanthracycline containing docetaxel-based combinations in metastatic breast cancer. Crown, J.[2019]

Docetaxel, when combined with cisplatin, shows promising efficacy in treating non-small cell lung cancer, with response rates between 32% to 52% and a median survival of 8 to 12 months based on phase II studies involving various patient populations.

The combination therapy is generally well-tolerated, with neutropenia being the main dose-limiting side effect, while severe neuropathy and nephrotoxicity are rare, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: trial data and implications for clinical management. Belani, C., Lynch, T.[2018]

Docetaxel, when combined with cisplatin, shows promising efficacy in treating non-small cell lung cancer, with response rates between 32% to 52% and a median survival of 8 to 12 months based on phase II studies involving multiple patients.

The combination therapy is generally well-tolerated, with neutropenia being the main dose-limiting side effect, while severe neuropathy and nephrotoxicity are rare, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: Trial data and implications for clinical management. Belani, C., Lynch, T.[2019]

Docetaxel shows comparable efficacy to paclitaxel in treating ovarian cancer, with a median progression-free survival of 16 months and a low neurotoxicity rate of 5%, significantly lower than the over 30% seen with paclitaxel.

In a large randomized trial involving 1077 patients, docetaxel combined with carboplatin demonstrated acceptable toxicity and treatment adherence, justifying further analysis of its safety and efficacy compared to the traditional paclitaxel-carboplatin regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The integration of docetaxel into first-line chemotherapy for ovarian cancer. Kaye, SB.[2019]

In a study comparing carboplatin combined with either paclitaxel or docetaxel in four ovarian carcinoma cell lines, both combinations showed a synergistic effect, enhancing the growth inhibitory impact on cancer cells.

The combination of carboplatin with paclitaxel produced a broader range of supra-additive effects across various concentrations compared to the carboplatin-docetaxel combination, suggesting that paclitaxel may be more effective in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin-paclitaxel- and carboplatin-docetaxel-induced cytotoxic effect in epithelial ovarian carcinoma in vitro. Engblom, P., Rantanen, V., Kulmala, J., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Docetaxel in combination with platinum compounds for non small-cell lung cancer. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in combination with platinum-based regimens in non-small cell lung cancer: results and future developments. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Phase II trial of docetaxel and carboplatin administered every 2 weeks as preoperative therapy for stage II or III breast cancer: NCCTG study N0338. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Nonanthracycline containing docetaxel-based combinations in metastatic breast cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: trial data and implications for clinical management. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: Trial data and implications for clinical management. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The integration of docetaxel into first-line chemotherapy for ovarian cancer. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

[Docetaxel and carboplatin for epithelial ovarian cancer]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Carboplatin-paclitaxel- and carboplatin-docetaxel-induced cytotoxic effect in epithelial ovarian carcinoma in vitro. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A phase II trial of docetaxel and carboplatin as first-line chemotherapy for metastatic breast cancer: NCCTG study N9932. [2018]