100 Participants Needed

Paclitaxel + Trastuzumab + Pertuzumab for Breast Cancer

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have received any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental therapy.

What data supports the effectiveness of the drug combination Paclitaxel, Trastuzumab, and Pertuzumab for breast cancer?

Research shows that adding pertuzumab to trastuzumab and chemotherapy, including paclitaxel, improves survival in patients with HER2-positive metastatic breast cancer. This combination is considered a standard treatment for this type of cancer.12345

Is the combination of Paclitaxel, Trastuzumab, and Pertuzumab generally safe for humans?

The combination of Trastuzumab and Pertuzumab with chemotherapy has been studied for safety, showing that while it can increase survival in breast cancer patients, it may also lead to side effects like diarrhea, skin issues, and low white blood cell counts. Cardiac safety is generally maintained, but monitoring is important, especially for those with existing heart conditions.15678

What makes the Paclitaxel + Trastuzumab + Pertuzumab drug combination unique for breast cancer?

This drug combination is unique because it targets HER2-positive breast cancer by using two different antibodies, trastuzumab and pertuzumab, which bind to different sites on the HER2 protein, enhancing the treatment's effectiveness. Paclitaxel, a chemotherapy drug, is added to further attack cancer cells, making this combination a standard first-line treatment for this type of breast cancer.12459

What is the purpose of this trial?

This trial tests a combination of three drugs to treat breast cancer. It aims to see if patients' responses can help decide their future treatment. The drugs work by stopping cancer growth and boosting the immune system to fight the cancer.

Research Team

Adrienne G. Waks, MD - Dana-Farber ...

Adrienne Waks, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with Stage II or III HER2-positive invasive breast cancer, who can provide consent and tissue samples. They must have a tumor size of at least 1.5 cm, no serious heart conditions, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and acceptable blood test results. Pregnant/nursing individuals, those with unresolved infections or significant cardiovascular disease are excluded.

Inclusion Criteria

The study requires testing for estrogen receptor (ER) and progesterone receptor (PR) status.
I am willing to use birth control during the trial.
I am fully active or restricted in physically strenuous activity but can do light work.
See 12 more

Exclusion Criteria

I have received treatment for my current breast cancer.
I experience significant discomfort or pain from nerve damage.
I do not have any serious diseases that could affect my treatment.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive Paclitaxel, Trastuzumab, and Pertuzumab intravenously in 21-day cycles before surgery

12 weeks
3 visits (in-person) per cycle

Surgery and Evaluation

Participants undergo surgery and evaluation of pathologic complete response (pCR)

4 weeks

Adjuvant Treatment

Participants receive antibody doublet therapy in the adjuvant setting based on response to neoadjuvant treatment

2.5 years

Follow-up

Participants are monitored for recurrence-free interval (RFI), event-free survival (EFS), and overall survival (OS)

12 years

Treatment Details

Interventions

  • Paclitaxel
  • Pertuzumab
  • Trastuzumab
Trial Overview The DAPHNe study tests if patients/doctors will choose post-surgery treatment based on pre-surgery response to a drug combo: Paclitaxel (Taxol), Trastuzumab (Herceptin), Pertuzumab (Perjeta). It also examines the collected blood/tissue from participants receiving these drugs for treating HER2-positive breast cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Paclitaxel+Trastuzumab+PertuzumabExperimental Treatment3 Interventions
Paclitaxel is administered intravenously on days 1, 8, and 15 of each 21-day cycle Trastuzumab is administered intravenously on day 1 of each 21-day cycle Pertuzumab is administered intravenously on Day 1 of each 21-day cycle

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

🇺🇸
Approved in United States as Taxol for:
  • Ovarian cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Kaposi's sarcoma
🇪🇺
Approved in European Union as Taxol for:
  • Ovarian cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Kaposi's sarcoma
🇨🇦
Approved in Canada as Paclitaxel for:
  • Ovarian cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Kaposi's sarcoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Terri Brodeur Breast Cancer Foundation

Collaborator

Trials
1
Recruited
100+

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials
68
Recruited
220,000+

Breast Cancer Research Foundation

Collaborator

Trials
79
Recruited
40,500+

Findings from Research

A study involving 808 patients with HER-2 positive breast cancer showed that adding pertuzumab to trastuzumab and docetaxel significantly improved overall survival, with a 3-year survival rate increase of 10% to 15%.
While pertuzumab did not worsen cardiac toxicity in patients with low cardiovascular risk, it was associated with increased side effects such as severe diarrhea and skin disorders, indicating the need for careful monitoring.
Pertuzumab. Promising for some women with metastatic breast cancer, but more assessment needed.[2016]
In a study of 152 patients with HER2-positive metastatic breast cancer, the combination of taxanes with trastuzumab and pertuzumab showed a significant progression-free survival (PFS) advantage over vinorelbine in patients with newly diagnosed metastatic disease, indicating a potential benefit for this specific group.
Overall, there was no significant difference in overall survival (OS) between the two treatment groups, suggesting that both taxanes and vinorelbine are viable options when combined with trastuzumab and pertuzumab for first-line treatment.
Taxane versus vinorelbine in combination with trastuzumab and pertuzumab for first-line treatment of metastatic HER2-positive breast cancer: a retrospective two-center study.Reinhorn, D., Kuchuk, I., Shochat, T., et al.[2021]
In a phase 3 trial involving 780 patients with HER2-positive metastatic gastric or gastro-oesophageal junction cancer, adding pertuzumab to trastuzumab and chemotherapy did not significantly improve overall survival compared to placebo, with median survival times of 17.5 months for the pertuzumab group and 14.2 months for the control group.
While serious adverse events were more common in the pertuzumab group (45%) compared to the control group (39%), no treatment-related deaths occurred in the pertuzumab group, suggesting a safety profile that warrants further investigation despite the lack of survival benefit.
Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study.Tabernero, J., Hoff, PM., Shen, L., et al.[2023]

References

Pertuzumab. Promising for some women with metastatic breast cancer, but more assessment needed. [2016]
Taxane versus vinorelbine in combination with trastuzumab and pertuzumab for first-line treatment of metastatic HER2-positive breast cancer: a retrospective two-center study. [2021]
Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. [2023]
Management of patients treated with pertuzumab in the Australian clinical practice setting. [2018]
Toxicity of dual HER2-blockade with pertuzumab added to anthracycline versus non-anthracycline containing chemotherapy as neoadjuvant treatment in HER2-positive breast cancer: The TRAIN-2 study. [2022]
Cardiac Safety of Dual Anti-HER2 Therapy in the Neoadjuvant Setting for Treatment of HER2-Positive Breast Cancer. [2018]
A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS). [2023]
Trastuzumab plus pertuzumab in combination with chemotherapy in metastatic HER2-positive breast cancer: a retrospective single-armed cohort study in China. [2022]
A novel HER2-targeting antibody 5G9 identified by large-scale trastuzumab-based screening exhibits potent synergistic antitumor activity. [2021]
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