44 Participants Needed

PaCT for Advanced Breast Cancer

ER
AC
Overseen ByAlyson Clayborn, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: Anthracyclines
Stay on Your Current MedsYou can continue your current medications while participating
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

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Clinton Yam | MD Anderson Cancer Center

Clinton Yam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.
See 11 more

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.
See 14 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (panitumumab, paclitaxel, carboplatin)Experimental Treatment3 Interventions

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

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Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+
Unbiased ResultsWe believe in providing patients with all the options.
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