Pre-Surgery Chemotherapy + Trastuzumab for Breast Cancer

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Prior chemotherapy, irradiation, surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a combination of chemotherapy drugs and trastuzumab, a monoclonal antibody, to treat breast cancer before surgery. The goal is to determine how effectively these treatments work together to shrink tumors and enhance surgical outcomes. The trial offers different treatment plans based on specific characteristics of the breast cancer, such as HER2 status, a protein influencing cancer growth. Individuals with stage IIA to IIIC breast cancer who have not yet undergone chemotherapy or surgery for this condition might be suitable candidates. Participants will also assist researchers by providing tissue samples, offering insights into how the treatment affects tumor cells. As an unphased trial, this study allows patients to contribute to groundbreaking research that could improve future breast cancer treatments.

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

The trial requires that you stop taking tamoxifen or other similar medications at least one week before enrolling. The protocol does not specify about other medications, so it's best to discuss with the trial team.

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

Research shows that the treatments in this trial are generally well-tolerated, though they have some known side effects.

The combination of paclitaxel and trastuzumab treats HER2-positive breast cancer. Studies have shown that this combination works well, but it can also cause side effects like tiredness, nausea, and sometimes heart problems.

The FDA has approved paclitaxel alone for treating breast cancer. It's effective but can cause side effects like hair loss and low blood cell counts, increasing the risk of infections.

The combination of doxorubicin and cyclophosphamide is a common chemotherapy treatment for breast cancer. It is effective but can cause side effects like nausea and a decrease in blood cells.

For hormone receptor-positive breast cancer, hormone therapy before surgery, known as neoadjuvant endocrine therapy, is used. Treatments like anastrozole and tamoxifen are generally well-tolerated but can cause symptoms like hot flashes and joint pain.

Overall, these treatments have been used for a long time, so their safety is well understood. Most side effects can be managed with proper care. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for breast cancer because they combine chemotherapy with targeted therapy, offering a potentially more effective approach for different cancer subtypes. Unlike standard treatments, which often rely solely on chemotherapy, the incorporation of Trastuzumab in HER2-positive patients targets specific cancer cell receptors, potentially enhancing treatment efficacy. Additionally, the use of neoadjuvant endocrine therapy for ER-positive, HER2-negative patients introduces hormone therapy before surgery, which could shrink tumors and make surgical procedures less invasive. Overall, this multi-faceted approach aims to improve outcomes by tailoring treatments to the cancer's specific characteristics.

What evidence suggests that this trial's treatments could be effective for breast cancer?

In this trial, participants with early-stage HER2-positive breast cancer will receive a combination of paclitaxel and trastuzumab. Research has shown that using paclitaxel and trastuzumab together is highly effective, with studies finding that 98.7% of patients remain cancer-free for at least three years. Adding trastuzumab to chemotherapy significantly reduces the chances of cancer recurrence and lowers the risk of death.

For participants with HER2-negative breast cancer, the trial includes treatment with paclitaxel, doxorubicin, and cyclophosphamide. This combination has demonstrated good results in stopping cancer cells from growing and spreading, leading to an 85.6% chance of being free from cancer events for five years.

In cases of ER-positive, HER2-negative breast cancer, participants may receive neoadjuvant endocrine therapy (NET) as part of the trial. Research suggests that NET can greatly improve surgical outcomes for these patients and has few side effects. ^{1 6 7 8 9}

Who Is on the Research Team?

Jesus Anampa, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with stage IIA-IIIC breast cancer who haven't had prior chemotherapy, radiation, or definitive surgery for the malignancy. They must have documented hormone receptor status and be medically fit for preoperative chemo and surgery. Prior tamoxifen use is allowed if stopped one week before enrollment.

Inclusion Criteria

I have had a biopsy or aspiration of my lymph nodes before starting treatment.

I have or will have metallic clips in my tumor before starting treatment to help with surgery.

I haven't had chemo, radiation, or major surgery for my cancer, but a sentinel lymph node biopsy is okay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Patients receive chemotherapy with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, with trastuzumab for HER2-positive patients

20 weeks

Weekly visits for paclitaxel, every 2 weeks for doxorubicin and cyclophosphamide

Surgery

Patients undergo surgery 2-6 weeks after the last chemotherapy dose

2-6 weeks post-chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• Doxorubicin Hydrochloride
• Paclitaxel
• Trastuzumab

Trial Overview The study tests pre-surgery chemotherapy using doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they kill tumor cells in breast cancer patients. It also involves collecting tissue samples to understand treatment response.

How Is the Trial Designed?

Group I: Stratum III: ER2-positive, HER2-negative Experimental Treatment 3 Interventions

Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET.

Group II: Stratum II: HER2-positive Experimental Treatment 6 Interventions

Patients receive Paclitaxel 80 mg/m\^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m\^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks.

Group III: Stratum I: HER2-negative Experimental Treatment 5 Interventions

Patients receive Paclitaxel 80 mg/m\^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m\^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks.

Group IV: Stratum C: HER2-negative Experimental Treatment 5 Interventions

Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks.

Group V: Stratum B: HER2-negative Experimental Treatment 5 Interventions

Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A.

Group VI: Stratum A: HER2-positive Experimental Treatment 6 Interventions

Patients receive Paclitaxel 80 mg/m\^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m\^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks.

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

Approved in United States as Cytoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in European Union as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482238/

Neoadjuvant therapy with eribulin, doxorubicin and ... Five-year event-free survival (EFS) was 85.6%. The regimen was tolerated with expected side effects—the most common grade 1 or 2 AEs were ...

2. lbbc.org lbbc.org/about-breast-cancer/treatments/chemotherapy/common-regimens/ac-adriamycin-cyclophosphamide

AC Chemotherapy Regimen Doxorubicin stops damaged cancer cells from continuing to grow, while cyclophosphamide stops cancer cells from reproducing. The medicines attack the cancer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00005970

Study Details | NCT00005970 | Doxorubicin Hydrochloride ... This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5905529/

Four cycles of adriamycin and cyclophosphamide followed ... Thirteen (10.7%) patients had stable disease. Clinical response was further improved following the docetaxel and trastuzumab treatment; complete ...

5. cancernetwork.com cancernetwork.com/view/docetaxeldoxorubicincyclophosphamide-treatment-metastatic-breast-cancer

Docetaxel/Doxorubicin/Cyclophosphamide in the ... Preliminary results from this study indicate that the Taxotere/Adriamycin/Cyclophosphamide(TAC) combination produces response rates of up to 80%.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10185890/

Effects of Adriamycin-Cytoxan chemotherapy on ... Adriamycin-Cytoxan (AC) is a common chemotherapy treatment for breast cancer (BC) patients. Its electrolyte and hematological adverse effects have not been ...

7. lbbc.org lbbc.org/about-breast-cancer/treatments/chemotherapy/common-regimens/ac-t-doxorubicin

AC-T Chemotherapy Regimen AC-T (doxorubicin and cyclophosphamide followed by paclitaxel), also called AC-T and AC-Taxol, is a chemotherapy combination treatment used to treat breast ...

8. drugs.com drugs.com/medical-answers/ac-adriamycin-cytoxan-cyclophosphamide-work-3537973/

How does Adriamycin and Cytoxan (AC chemo) work for ... The combination of Adriamycin and cyclophosphamide is considered a “tried-and-true”, common, regimen to treat localized breast cancer.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7154379/

Addition of drug/s to a chemotherapy regimen for metastatic ... Compared with single‐chemotherapy agents, combination regimens show a statistically significant advantage for tumour response and time to progression in women ...