April 8, 2020 Breast Adjuvant

Clinical Trial Information

SCHEMA S1418- BR006

PROTOCOL: SWOG-S1418 (NRG-BR006)

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Patients must have histologically confirmed ER-, PR- and HER2-negative breast cancer (triple-negative, TNBC) or ER- and PR- weakly positive and/or HER2- equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy. Patients who are HER2-positive by ASCO CAP guidelines are
    ineligible. HER2-negative and HER2-equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible. Patients with weakly ER or PR positive disease, defined as ER and/or PR less than or equal to (≤) 5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy. Residual disease must be ≥ 1 cm in greatest dimension, and/or have positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) observed on pathologic exam.

    1. NOTE: If the ER and/or HER2 results are discordant between the initial, prechemotherapy, and post-chemotherapy surgical tissue, the receptor status of the residual disease has to be used to determine eligibility. IHC-positive isolated tumor
      cells in the lymph node (N0 [i+]) are not considered node-positive and these patients also must have ≥ 1 cm residual invasive cancer in the breast to be eligible.
  2. Patients must not have metastatic disease (i.e., must be clinically M0 or Mx; systemic staging studies with imaging should follow routine practice. Patients must not have locally recurrent disease.
  3. It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response. Patients must have a complete axillary lymph node dissection (ALND) after neoadjuvant chemotherapy in the following situations:
    1. Patients had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s).
    2. Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy.
    3. NOTE: Patients who undergo sentinel node biopsy before starting neoadjuvant treatment and do not undergo post neoadjuvant assessment of the axillary nodes or who have negative axillary nodes on post neoadjuvant assessment must have
      ≥ 1 cm residual invasive cancer in the breast after completion of neoadjuvant chemotherapy.
  4. Patients must have had neoadjuvant chemotherapy followed by surgery. The choice of neoadjuvant chemotherapy is determined by the treating physician.
  5. Patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease.
  6. Patients must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS within the following timelines:
    1. 90 days prior to Step 1 screening registration for patients not receiving post-operative (adjuvant) chemotherapy OR
    2. 270 days prior to Step 1 screening registration for patients who have received post-operative (adjuvant) chemotherapy.
  7. Positive margins are allowed only if the surgical team of the patient deems further resection impossible.
  8. Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, antiCTLA4 or similar drugs.
  9. Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol. However, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may
    continue with their endocrine therapy. Elective surgery or surgery that is not related to cancer therapy is allowed, at the discretion of the treating investigator.
  10. Patients must be ≥ 18 years of age.
  11. Patients must have Zubrod Performance Status ≤ 2.
  12. No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years.


April 8, 2020 Breast Adjuvant

Clinical Trial Information

SCHEMA NRG-BR003

PROTOCOL: NRG-BR003

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. The trial is open to female and male patients. Age ≥ 18 years.
  2. ECOG Performance Status of 0 or 1.
  3. The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  4. All of the following staging criteria must be met:
    1.   By pathologic evaluation, primary tumor must be pT1-3
    2. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c),
      pN2a, pN2b, pN3a, or pN3b.
    3. If pN0, pathological tumor must be ≥ 3.0 cm.
  5. The tumor must have been determined to be HER2-negative as follows.
  6. The tumor must have ER and PgR status assessed.
  7. The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy.
  8. For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be
    performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
  9. For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible as long as post-mastectomy RT of the chest wall will be administered.)
  10. The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.
    1. Sentinel lymphadenectomy alone:
      − If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;
      − If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the
      patient has undergone breast conserving surgery (with planned breast radiotherapy), the
      primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must
      be limited to 1 or 2 positive nodes.
    2. Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
    3. Axillary lymphadenectomy with or without SN isolation procedure.
  11. The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days.
  12.  No T4 tumors including inflammatory breast cancer.
  13. No synchronous or previous contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
  14. No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
  15.  No history of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.
  16.  No previous therapy with anthracyclines or taxanes for any malignancy.
  17. No chemotherapy administered for the currently diagnosed breast cancer prior to randomization.


April 8, 2020 Breast Adjuvant

Clinical Trial Information

SCHEMA EA1131

PROTOCOL: ECOG-EA1131

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Age ≥ 18 years.
  2. ECOG Performance Status 0 or 1 within 2 weeks prior to screening.
  3. Female and male patients must have histologically confirmed invasive breast cancer.
    1. Clinical stage II or III at diagnosis, based
      on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed.
    2. ER- and PR- should meet one of the following criteria:
      ≤ 10% cells stain positive, with weak intensity score
      ≤ 1% cells stain positive.
    3. HER2 negative (not eligible for anti-HER2 therapy) will be
      defined as:
      IHC 0, 1+ without ISH HER2/neu chromosome 17 ratio OR
      IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells OR
      ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells without IHC)
  4. Patients must have completed neoadjuvant taxane +/- anthracycline. Patients must NOT have received cisplatin or carboplatin or
    capecitabine as part of their neoadjuvant therapy regimen.
  5. Must have completed definitive resection of primary tumor.
  6. Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery.
  7. Radiotherapy may be given before or after protocol treatment per standard of care guidelines. When radiotherapy is planned prior to
    protocol treatment administration, patients may be registered and screened while receiving radiation.
  8. No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort.
  9. Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed. LHRH agonists and adjuvant bisphosphonate or denosumab use is allowed.


April 7, 2020 Breast Adjuvant

Clinical Trial Information

SCHEMA A011502

PROTOCOL: ALLIANCE-A011502

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Histologic documentation of women or men with HER2 negative breast carcinoma. If ER and PR negative, tumor must be node positive or >2 cm and node negative. Patients must be registered within 18 months of diagnosis. pN1mic is eligible. If ER and/or PR positive, tumor must be node positive and within 10 years of diagnosis. pN1mic is eligible.
  2. Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed.
  3. Prior regular NSAID/aspirin use (defined as ≥ 5 days per week) at any dose (including baby aspirin) allowed if stopped for at least 30 days prior to study entry and throughout study period.
  4. If ER and/or PR positive, tumor must be node positive and within 10 years of diagnosis. pN1mic is eligible.
  5. Patients must be > 18 and < 70 years of age.
  6. ECOG performance status 0-2.
  7. No chronic (duration >30 days) daily use of oral steroids. Inhaled or topical steroids are allowed.
  8. No prior invasive malignancy of any type within the past 5 years.
  9. Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.
  10. No history of metastatic breast cancer.

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