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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of three drugs—panitumumab (Vectibix), carboplatin (Paraplatin or Carboplatinum), and paclitaxel (Taxol, Onxol, or Abraxane)—to evaluate their effectiveness against triple-negative breast cancer (TNBC). The goal is to shrink the tumor before surgery, making it easier to remove and potentially reducing the amount of healthy tissue excised. The trial seeks participants recently diagnosed with TNBC that has not spread beyond the breast and nearby lymph nodes, who have already tried an anthracycline-based treatment without success. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude patients who are using hormonal therapy or receiving radiation therapy at the same time, so you may need to discuss your specific medications with the trial team.

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

Research has shown that the combination of panitumumab, carboplatin, and paclitaxel is generally well-tolerated by patients. In studies, patients often experienced common side effects such as tiredness, nausea, and low blood cell counts. These side effects are typical for chemotherapy drugs like carboplatin and paclitaxel. Panitumumab, an immunotherapy, may also cause skin rashes and low magnesium levels in the blood.

While side effects can occur, they are usually manageable with medical care. Serious side effects are less common but can happen. This trial is in an early phase, indicating that earlier studies have demonstrated sufficient safety to proceed to this stage of testing. It is important to discuss potential risks and benefits with healthcare providers before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for breast cancer?

Researchers are excited about this combination treatment for advanced breast cancer because it brings together the power of three drugs: carboplatin, paclitaxel, and panitumumab. Unlike standard treatments that typically focus on chemotherapy alone, this approach includes panitumumab, an antibody that specifically targets the epidermal growth factor receptor (EGFR), potentially enhancing the effectiveness of chemotherapy. By targeting EGFR, panitumumab may inhibit cancer cell growth more effectively, offering hope for improved outcomes in patients who have limited options. This unique combination aims to attack cancer cells more comprehensively, providing a promising new strategy in advanced breast cancer care.

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

In this trial, participants will receive a combination of three drugs—panitumumab, carboplatin, and paclitaxel—to treat advanced breast cancer. Research has shown that this combination can effectively treat certain types of breast cancer. One study found that administering these drugs together before surgery can shrink tumors and reduce the need to remove healthy tissue. Panitumumab aids the immune system in fighting cancer and inhibits tumor cell growth. Carboplatin and paclitaxel are chemotherapy drugs that kill cancer cells or prevent their spread. Together, these treatments have shown promise in making tumors smaller and easier to manage. ^{1 2 3 5 6}

Who Is on the Research Team?

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.

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 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?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01036087?term=AREA%5BIdSearch%5D(%22NCT00894504%22OR%22NCT01009983%22OR%22NCT01036087%22)&rank=1&tab=results

Study Results | Panitumumab, Nab-paclitaxel and ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6143003/

Safety and Efficacy of Panitumumab Plus Neoadjuvant ... Patients received 1 dose of panitumumab (2.5 mg/kg) followed by 4 cycles of panitumumab (2.5 mg/kg), nab-paclitaxel (100 mg/m2), and carboplatin ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.1087

Phase II study of panitumumab, nab-paclitaxel, and ... Phase II study of panitumumab, nab-paclitaxel, and carboplatin followed by FEC neoadjuvant chemotherapy for patients with primary HER2-negative ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4622683/

A phase II clinical trial of weekly paclitaxel and carboplatin ... Conclusions: In our experience the response rate of carboplatin, paclitaxel and panitumumab was consistent with other reports of response for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02876107

Carboplatin and Paclitaxel With or Without Panitumumab in ... Giving carboplatin and paclitaxel with or without panitumumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT02876107/

Clinical Trial: NCT02876107 - Breast Cancer Giving carboplatin and paclitaxel with or without panitumumab before surgery may make the tumor smaller and reduce the amount of normal tissue ...