(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response

Official Summary

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as 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. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 2,175 participants

Interventions

• DRUG: Docetaxel — Given IV
• PROCEDURE: Lumpectomy — Undergo lumpectomy
• PROCEDURE: Mastectomy — Undergo mastectomy
• DRUG: Nab-paclitaxel — Given IV
• DRUG: Paclitaxel — Given IV

Primary Outcomes

• Recurrence-free survival (RFS) (Up to 3 years after end of treatment)

Secondary Outcomes

• Invasive disease-free survival (IDFS) (Up to 3 years after the end of treatment)
• Distant disease-free survival (DDFS) (Up to 3 years after the end of treatment)
• Distant relapse-free survival (DRFS) (U to 3 years after the end of treatment)
• Recurrence-free interval (RFI) (Up to 3 years after the end of treatment)
• Overall survival (OS) (From date of surgery until the date of death from any cause, assessed up to 3 years after the end of treatment)

Eligibility Criteria

Inclusion Criteria:

* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma, determined by local testing. The tumor must have either HER2 IHC result of 3+ or HER2/CEP17 ratio \> 2 with \> 4.0 HER2 signals per cell by ISH. Tumors with HER2/CEP17 ISH ratio \< 2 are ineligible, even if HER2 copy number is \> 6, unless HER2 IHC result is 3+.
* Patients hormone receptor (estrogen receptor \[ER\] and progesterone receptor \[PR\]) status must be known and will be determined by local testing. Patients with either hormone receptor -positive or hormone receptor- negative HER2-positive breast cancer are eligible
* Patients must have AJCC 8th Edition stage II or IIIa according to anatomic staging table at diagnosis

  * Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-3)
  * Patients with nodal involvement (cN1-2) are eligible if T1-3
  * Patients with clinical T4 or N3 disease are not eligible
* Patient must be willing and able (i.e., have no contraindication) to receive standard adjuvant therapy, consisting of HER2-directed therapy, radiation (if indicated) and endocrine therapy (if ER+) if achieving pCR at surgery
* Patient with bilateral invasive breast cancers are eligible if both cancers are HER2-positive (as defined in 3.1.3) at least one meets protocol eligibility and neither cancer renders the patient ineligible (i.e. per eligibility 3.1.5)
* Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive, and at least one tumor focus meets eligibility criteria (per eligibility 3.1.5). Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing. However, even if biopsy is not deemed necessary, consideration should be given to placing a clip in any lesion that is 1 cm or further from the primary tumor to ensure that all tumor is removed at surgery AND that the pathologist can locate all primary sites of tumor to assess pathologic response at surgery.
* Patients with a history of other non-breast malignancies are eligible if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy.

  * Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, and localized papillary or follicular thyroid cancer who have completed recommended treatment including surgery. Patients with any other cancers within the last 5 years are ineligible.
* Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or \> 50%)
* Patients must not have \> grade 1 peripheral neuropathy of any etiology.
* Patients must have a bilateral mammogram and a diagnostic breast ultrasound \[on the side of the cancer(s)\] (with or without breast MRI) performed at screening. An axillary ultrasound on the side of the cancer(s) is also required. However, if a patient has a negative axillary physical exam and a baseline MRI without suspicious lymph nodes performed before axillary ultrasound, axillary ultrasound may be omitted. Comprehensive breast and axillary imaging must be performed within 42 days of registration (i.e. the patient's mammogram/ breast ultrasound /axillary ultrasound OR their breast MRI).
* Baseline imaging of the ipsilateral axilla by ultrasound or breast MRI is mandatory. For subjects with axillary lymph node(s) suspicious on clinical exam or imaging, patient must be willing to have a needle aspiration or core biopsy to determine the presence of metastatic disease in the lymph nodes. A clip must be placed in the involved axillary lymph node. (If there are more than 1 suspicious axillary nodes, only one clipped node is required).
* Patient of childbearing potential and sexually active patients must use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 7 months after the last dose of study treatment.
* Patient must be willing and able to sign informed consent
* Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to protocol registration)
* Absolute neutrophil count \>= 1,500/mcL (obtained =\< 28 days prior to protocol registration)
* Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol registration)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained =\< 28 days prior to protocol registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 28 days prior to protocol r

Trial Locations

• University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
• Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
• Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
• Alaska Women's Cancer Care, Anchorage, Alaska, United States
• Anchorage Oncology Centre, Anchorage, Alaska, United States
• Katmai Oncology Group, Anchorage, Alaska, United States
• Providence Alaska Medical Center, Anchorage, Alaska, United States
• Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
• ...and 10 more locations

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