PaCT for Advanced Breast Cancer

Overseen By Alyson Clayborn, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Anthracyclines

Must not be taking: Hormonal therapy, Radiation therapy

Disqualifiers: Pregnancy, Prior malignancy, Cardiac events, others

Stay on Your Current Meds You can continue your current medications while participating

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: 7

Duration: 12 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well panitumumab, carboplatin and paclitaxel work in treating patients with newly diagnosed triple negative breast cancer that is limited to the breast and possibly to the nearby lymph nodes (locally advanced). This treatment study is linked to NCI-2015-00191 protocol, which uses a baseline biopsy to determine the neoadjuvant therapy that matches the sub-type of triple negative breast cancer (TNBC). Immunotherapy with panitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab, carboplatin and paclitaxel before surgery may be an effective treatment for breast cancer by making the tumor smaller and reducing the amount of normal tissue that needs to be removed.

Research Team

Clinton Yam, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women with newly diagnosed triple negative breast cancer that hasn't spread beyond the breast or nearby lymph nodes. Participants must have had some prior chemotherapy, be in good physical condition (ECOG 0-1), and have adequate organ function. Men are excluded, as are pregnant or breastfeeding women, those unwilling to use contraception, anyone with a history of certain cancers within 5 years, and patients with specific medical conditions.

Inclusion Criteria

My tumor or affected lymph node is at least 1cm in size after initial chemotherapy.

My breast cancer is triple-negative.

I am fully active or have some restrictions but can still carry out light work.

Exclusion Criteria

I haven't had cancer, except for certain skin, cervical, or breast cancers, in the last 5 years.

I am not pregnant or breastfeeding.

You have tested positive for HIV, hepatitis C, or have active hepatitis B infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive panitumumab, carboplatin, and paclitaxel intravenously. Treatment repeats every 21 days for up to 4 cycles.

12 weeks

4 cycles with visits on days 1, 8, and 15 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 2 years

Every 3-4 months

Treatment Details

Interventions

• Carboplatin
• Paclitaxel
• Panitumumab

Trial Overview The study tests panitumumab combined with carboplatin and paclitaxel before surgery in treating locally advanced triple negative breast cancer. Panitumumab is an immunotherapy drug that may help the immune system fight cancer cells. Carboplatin and paclitaxel are chemotherapy drugs aimed at stopping tumor growth by killing or preventing cell division.

Participant Groups

Group I: Treatment (panitumumab, paclitaxel, carboplatin) Experimental Treatment 3 Interventions

Patients receive panitumumab IV over 30 minutes and paclitaxel IV over 30 minutes on days 1, 8, and 15. Patients also receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+