Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Letrozole

Estrogens

Goserelin

Anastrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.

Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.

Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.

goserelin acetate

letrozole

anastrozole

chemotherapy

Surgery

Timothy Pluard, M.D.

This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body. E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth. Giving goserelin together with letrozole or anastrozole before surgery may enhance the effectiveness of, or eliminate the need for, chemotherapy

Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

A Multisite International Collaborative Phase 2 Study of Neoadjuvant Goserelin and a Non-steroidal Aromatase Inhibitor for Premenopausal Women With Estrogen Receptor Positive HER2 Negative Clinical Stage 2 and 3 Breast Cancer

* In patients with Ki67 \>10% and \<= 15 pg/ml at 4 weeks.
* The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.

Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.

To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).

National Cancer Institute (NCI)

Washington University School of Medicine

Group 1 (Ki67 <10%, E2 <= 15 pg/ml)

Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)

Group 3 (E2 > 15 pg/ml)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 \>10% and estradiol levels of \<= 15 pg/ml at 4 weeks.

Pathologic Complete Response (CR) Rate

None of the participants had a PEPI score and 0 and pathological stage 1.

Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy

This outcome was not analyzed due to funding issues.

Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67

PEPI Score 1

PEPI Score 4

PEPI Score 7

PEPI Score 8

2 participants in Group 1 did not have a PEPI score at time of surgery as (1) participant did not have nodal dissection and (1) did not have surgery. Both participants in Group 2 and Group 3 did not have surgery study tissue collected

Preoperative Endocrine Prognostic Index Score (PEPI Score)

(1) of the participants in Group 1 had an inconclusive PEPI score at week 16 and was not evaluable. (1) of the participants in Group 1 did not have surgery and was not evaluable. Participants in Group 2 and Group 3 were not evaluable for this outcome as the estradiol and Ki67 levels were above outcome specified levels.

Spots Global Cancer Trial Database for Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

Trial Identification

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Interventions

Study Description

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