Carboplatin + Docetaxel for Breast Cancer

(CADENCE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of two chemotherapy drugs, docetaxel and carboplatin, can effectively treat triple-negative breast cancer. This type of breast cancer lacks certain common receptors, making it harder to treat. Suitable candidates for the trial have been diagnosed with invasive breast cancer that is both estrogen receptor-negative and HER2-negative. Participants should have a primary breast tumor of at least 2 cm and must not have received any systemic therapy for breast cancer in the last five years. The trial aims to assess how well this drug combination shrinks tumors and improves patient outcomes. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to significant advancements in cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining docetaxel and carboplatin is generally well-tolerated by patients. One study found no major safety concerns for early breast cancer patients in the Asia-Pacific region using this drug combination. Another study on patients with advanced cancers found the treatment both safe and effective.

These drugs are often used to treat various types of cancer, indicating confidence in their safety. While side effects can occur, research indicates that serious side effects are uncommon with this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Researchers are excited about using carboplatin and docetaxel together for treating breast cancer because this combination may enhance the effectiveness of chemotherapy. Unlike standard treatments that often focus solely on traditional drugs like anthracyclines or taxanes, this approach combines a platinum-based drug (carboplatin) with a taxane (docetaxel), potentially overcoming resistance to other therapies. The synergy between these two drugs could lead to better tumor reduction and improved outcomes for patients, offering new hope for those who have limited responses to existing treatments.

What evidence suggests that this treatment might be an effective treatment for triple negative breast cancer?

Studies have shown that using the drugs docetaxel and carboplatin together can effectively treat breast cancer. Earlier research reported a 60% overall response rate with this combination, indicating that many patients experienced a reduction or disappearance of their cancer. Specifically, 6% of patients saw their cancer completely disappear, while 54% saw it shrink. Another study found that this treatment increased the rate of complete cancer disappearance compared to other drug combinations. These findings suggest that using docetaxel and carboplatin together might be a promising option for treating triple-negative breast cancer. Participants in this trial will receive this combination treatment to further evaluate its effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Mothaffar Rimawi, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16118507/

A phase II trial of docetaxel and carboplatin as first-line ... Overall response rate was 60%, with 3 complete responses (6%) and 29 partial responses (54%). Median time to disease progression was 9.6 months. Median survival ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3493827/

A Phase II trial of docetaxel and carboplatin administered ... In a randomized comparison of 6 versus 3 of epidoxorubicin/docetaxel combination for stage II or III breast cancer, pCR rate of 36% compared to 10% was seen ...

3. withpower.com withpower.com/trial/carboplatin-docetaxel-for-breast-cancer-a6f20

Carboplatin + Docetaxel for Breast Cancer (CADENCE Trial) In a dose-finding study, the combination of docetaxel and cisplatin showed a promising response rate of 60% in patients with metastatic breast cancer, ...

4. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/publications/carboplatin-in-combination-therapy-for-metastatic-breast-cancer

Carboplatin in combination therapy for metastatic breast ... Single-agent carboplatin is active in patients with previously untreated metastatic breast cancer, producing response rates of 20%-35%. Preclinical studies have ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02547987

Neoadjuvant Carboplatin and Docetaxel in Triple Negative ... The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10628556/

Twenty-Year Follow-Up of a Phase II Trial of Taxotere ... This is a 20-year follow-up study of a phase II trial that evaluated the activity and safety of docetaxel in combination with carboplatin and trastuzumab (TCH) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4705087/

Based Chemotherapy in Early Breast Cancer Patients ... Docetaxel-based chemotherapy did not show any significant safety concerns for early breast cancer patients of the Asia-Pacific region.

8. macmillan.org.uk macmillan.org.uk/cancer-information-and-support/treatments-and-drugs/docetaxel-and-carboplatin

Docetaxel (Taxotere ®) and carboplatin Docetaxel and carboplatin is a combination of chemotherapy drugs. It is used to treat breast cancer. It may sometimes be used to treat other cancers.

9. cancernetwork.com cancernetwork.com/view/first-line-carboplatindocetaxel-safe-effective-advanced-ovarian-cancer

First-Line Carboplatin/Docetaxel Safe, Effective for ... Among 30 patients who have completed 6 cycles of treatment and were considered clinically evaluable, the overall response rate was 67% and the CA 125 response ...